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PRINCIPAL STATISTICIAN

Principal biostatistician | clinical | pharma (fsp) top global pharma (fsp) via global cro fully remote fte who will you be working with? you'll be dedicated to a global pharmaceutical powerhouse driven by science, powered by data, and inspired by a ...


PHARMACOVIGILANCE ASSOCIATE

Home based icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of c...


LATAM SENIOR PHARMACOVIGILANCE ANALYST

Latam senior pharmacovigilance analyst page is loaded latam senior pharmacovigilance analyst apply locations bogota, colombia time type full time posted on posted yesterday time left to apply end date: july 11, 2025 (1 day left to apply) job requisition id r1492325 job overview key responsibilities:
- team leadership: lead a small local team, providing guidance and support to ensure effective execution of psp activities across latam. - project management: oversee multiple pharmacovigilance projects simultaneously, ensuring timely and accurate reporting of aes. - client audits: conduct face-to-face and remote client audits throughout the year to ensure compliance and address client needs. - kpi metrics: develop and monitor key performance indicators (kpis) for psp support across the region, ensuring targets are met. - adverse event reporting: prepare and deliver detailed ae reports to clients in latam, maintaining high standards of accuracy and clarity. - training and development: provide pharmacovigilance training to team members and other stakeholders involved in the projects. - data review: conduct thorough reviews of data sources generated for each project to identify and report aes. - reconciliation process: manage the reconciliation process for each project, ensuring data consistency and accuracy. - e2e process analysis: analyze the e2e process to identify areas for improvement and implement best practices. - source data verification: perform source data verification to ensure the integrity and accuracy of reviewed data. - cross-functional collaboration: work c...


PROJECT MANAGER

For project management services. what makes you a fit: the technical part: bachelor of science in engineering (mechanical or electrical) and at least five (5) years of experience in project management within the pharmaceutical industry. shift: administrative, with flexibility based on business needs. bilingual: english and spanish (verbal and written). experience in: project management lifecycle: scope of work, cost estimation, procurement, bidding process, scheduling, project control, contractor supervision, and start-up. managing projects for utilities, fire protection systems, lightning protection, and purified water systems. understanding of pharmaceutical manufacturing processes, regulations, and industry best practices. the personality part: we seek someone who treats everyone like family—our resources, clients, and team members. a customer service-oriented professional with innovative ideas and a commitment to top-quality results. are you ready to be the piece? as a piece of fits, you will: (the day-to-day on the job) manage all aspects of projects: planning, implementation, monitoring, completion, and follow-up. prioritize critical tasks and manage competing timelines. establish and meet project standards for quality and quantity. assess issues and develop solutions to meet scientific, productivity, quality, and client satisfaction goals. research issues, provide recommendations, and maintain documentation to support technical, financial, and organizational decisions. maintain and track project budgets. allocate and reconcile resources effectively. identify schedule...


COMMERCIAL PRICING MANAGER (BOGOTÁ)

Join amgen’s mission of serving patients at amgen, if you feel like you’re part of something bigger, it’s because you are. our shared mission—to serve patients living with serious illnesses—drives all that we do. since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. with our focus on four therapeutic areas –oncology, inflammation, general medicine, and rare disease– we reach millions of patients each year. as a member of the amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. our award-winning culture is collaborative, innovative, and science based. if you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the amgen team. join us and transform the lives of patients while transforming your career. commercial pricing manager ( bogotá) what you will do let’s do this. let’s change the world. in this vital role you will a strategic and results-driven pricing manager to join our team in colombia, focusing on the pharmaceutical and biotechnology sectors. this critical role will be responsible for designing, implementing, and monitoring pricing strategies that align with business objectives, ensure regulatory compliance, and strengthen our competitive position in the market. the pricing manager will collaborate with cross-functional teams to drive profitability and optimize pricing models for innovative therapies and pharmaceutical products: pricing strat...


MSL ONCOLOGY - FU-329

**responsibilities** - the msl is expected to comply with all ipsen sops, policies, directive, and relevant national guidelines. - achieve the communication of medical and educational objectives set for the assigned products/indications, within the framework of ipsen’s national strategy. (communication plan) - develop, maintain, and support professional relationships with internal and external customers (e.g., key thought leaders [ktl], health care professionals [hcps], and formulary decision makers). - facilitate informational, educational, and research activities for physicians and ancillary healthcare professionals regarding ipsen’s current and pipeline therapies. - ensure that the scientific and technical needs of medical affairs, clinical development and commercial colleagues are identified and met working closely with other ipsen personnel-- document, accurately and in a timely manner, the aforementioned activities. - maintain up-to-date knowledge of relevant scientific information (by performing literature searches, participation in medical congresses and conferences of relevance to ipsen’s disease and therapeutic area interests). - disseminate this knowledge as appropriate to hcps in response to requests, in accordance with applicable laws. - proactively provide fair, balanced, and transparent medical and scientific exchange in disease area management. - current and potential sources of clinical and scientific expertise (known experts, rising stars etc.) - current and potential principal investigators, speakers - informational needs of indi...


CRA II | (U-396)

As clinical research associate (cra), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. a cra is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. you will be partnering with one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. this global pharmaceutical client develops breakthrough innovative medicines to improve and extend the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance. **what you will be doing**: - completes onsite and remote monitoring activities in accordance with all ich-gcp guidelines, applicable regulations, sops and study processes. - verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations. - ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, gcp, applicable regulations and sops. - writes and submits reports of investigational site findings and updates applicable tracking systems. escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate. - participates in audit preparation and follow-up activities as needed. - may serve as preceptor, providing training to less experienced clinical team members. ...


MJ734 PRINCIPAL CLINICAL DATA SCIENCE LEAD

Icon plc is a world-leading healthcare intelligence and clinical research organization. from molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. with our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. our people are our greatest strength, are at the core of our culture, and the driving force behind our success. icon people have a mission to succeed and a passion that ensures what we do, we do well. we have an incredible opportunity for a **principal clinical data science lead** to join icon. **locations**: - mexico (office-based with remote flexibility) - colombia (office-based or home-based) **overview of the role**: this principal clinical data science lead (cdsl) role is part of the early phase data management department and is responsible for managing data management teams, studies, and programs of studies under the general direction of the senior manager/director of data management. the principal cdsl will provide planning estimates for project scope, schedule, and resource requirements, and ensures that studies are properly managed and delivered. they will work with clinical operations, biostatistics, sas programming, medical writing, and quality assurance to ensure that data collected during trials is managed according to corporate standards and meets regulatory guidelines for data integrity. the early phase service line of the co...


RJ572 MARKETING SPECIALIST CATCH PROGRAM

If you are looking to step up your career, abbvie is the place for you: we are looking for a marketing specialist for our catch program. as a marketing specialist, you will work closely with the field teams to deploy marketing initiatives, coordinating all activities related to marketing materials and supporting other processes related to the field teams, putting the patient at the center of any efforts and operating within abbvie's code of business conduct, policies and all applicable laws and regulations. major responsibilities: - actively engage with multiple stakeholders in order to foster gathering of insights. - support implementation of marketing-led initiatives including supporting coordination with partner agencies to deliver appropriate campaign content, logistic support for cycle and kick-off meetings, patient-focused solutions and multi-channel and digital campaigns. - share in-field best practices, and support in field teams in their tactical executions in order to align in-field team activities - support marketing colleagues in the development of marketing materials, in gathering information for forecasting, kpi monitoring and budget tracking as appropriate. - liaise with commercial excellence to execute market research and customer interviews to inform brand planning. qualifications: - bachelor’s degree or equivalent, marketing qualifications preferred. - digital knowledge and experience (must). - 2+ years of work experience. - advanced english. - analytical skills to transform data into actionable plans. - good communication. - knowledge o...


[MCJ-15] - MSL

**_ accountabilities:_** - participate in scientific discussions with health professionals, positioning the molecules developed by takeda, based on complete, updated, and balanced information and guaranteeing patient safety. - provide the scientific perspective for designing and developing the medical plan and brand plan based on the insights collected in their field. - support takeda's research studies conducted in the loc and support the cros with the specific requirements of the studies defined in the plans. - create or support the development of medical/scientific materials and slide decks - review and prepare training materials for the medical area (with the ta lead/medical manager); provide clinical presentations and medical information to internal stakeholders. - contribute to the development and execution of the medical strategy, according to local distribution and their respective therapeutic areas, and contribute to developing strategies for the brand plan. - develop solid and sustainable relationships based on scientific credibility with external stakeholders, healthcare professionals (hcps) - physicians, and nurses - including key opinion leaders (locs), to support the medical/scientific credibility of the company. - establish trust relationships with health professionals based on scientific concepts to disseminate the medical communication plan, position relevant medical concepts, identify their knowledge needs, and propose strategies to nurture the medical plan. - manage activities related to health professionals, carry out the appropriate segmentatio...


(FW14) DATA ANALYST MEDIA - MANAGER

1. our position - _ data analyst media - manager_ - _ bogotá, colombia_ 2. about the job our team: you will have a pivotal position to accelerate the web sites agenda in sanofi consumer health care, working closely with web sites from the most relevant pharmaceutical brands in the market (buscapina, allegra, novalgina, pharmaton, doflex, etc), and technically contributing to build a more data driven company, building strong web sites that will become an important data hub to drive strategies in all latam region. main responsibilities: - research and effectiveness measurement. - work with bi tools (power bi, data studio - work with different media platforms (google marketing platform, facebook business manager) - website analytics (google analytics), social listening techniques and crm practices - programming language (r or python) - work with cloud platforms (big query, google cloud, google ads data hub) - understand the levers a digital marketer may pull to influence marketing outcomes - understand the implications of data protection regulations on technologies and process. - work with diverse data sources across multiple channels to produce insight. 3. about you - experience: experience in digital marketing data analysis. - education: bachelor’s degree (b.a.) or equivalent in information technology, business, engineering or pharmacy bachelor's degree. mba desired. - languages: fluent spoken and written english and spanish 4. pursue progress, discover extraordinary better is out there. better medications, better outcomes, better science. but pro...


CLINICAL DATA LEAD [CU513]

Icon plc is a world-leading healthcare intelligence and clinical research organization. from molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. with our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. our people are our greatest strength, are at the core of our culture, and the driving force behind our success. icon people have a mission to succeed and a passion that ensures what we do, we do well. we have an incredible opportunity for a **clinical data lead** to join the team. **location**: - mexico (home based - colombia (home based) **overview of the role**: as a clinical data lead (cdl) you will be the point of contact for day to day activity on a study with key responsibilities for study set-up and close-out tasks as well as overseeing and coordinating tasks delegated to the study team members both locally and in other offices. you will also coordinate with data management teams, studies and programs of studies and independently oversee the performance of data management activities on multiple studies. - independently prepare all materials and take part in study kick off (internal and external) meeting. - review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the dmpm and contract analyst. - lead the development of specifications, implementation, and testing for the ecrf or paper crf. ...


EFS-068 - ASISTENTE CONTABLE

Compañía comercializadora de insumos y material de empaque para el sector farmacéutico requiere tecnólogo en contaduría graduado o estudiante de últimos semestres de contaduría, con excelente manejo de excel y programas contables. conocimientos y experiência en cuentas por cobrar, cuentas por pagar, facturación, nómina y prestaciones. horario de lunes a viernes de 7am a 5pm, presencial. tipo de puesto: tiempo completo salario: $1.450.000 - $1.500.000 al mes consideraciones ante el covid-19: uso tapabocas, aseo limpieza desinfección instalaciones,...


NEUROLOGY BRAND MANAGER | (UPK-302)

At lilly, we unite caring with discovery to make life better for people around the world. we are a global healthcare leader headquartered in indianapolis, indiana. our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. we give our best effort to our work, and we put people first. we’re looking for people who are determined to make life better for people around the world. - bogotá - company overview - eli lilly is global pharmaceutical company with operations throughout the world. our goal is to unite caring with discovery to make life better for people around the world. we have been helping to make lives better for patients for more than 140 years. we are a leader in research and development, with a strong base of currently marketed brands and pipeline of future innovations. we invest in our people through a competitive package of salary and benefits, training and development, and career advancement opportunities. - neurology brand manager - this marketing leadership role is responsible for delivering world class product launch preparation and launches for the neurology portfolio in colombia. lead development and execution of neurology customer plans. achieve revenues and som targets. coach and develop marketers, ensure alignment with ibu customer plans, replication of best practices. review results with colombia, regional and ibu lead teams, take necessary measures to close the gaps. ensu...


[G216] AUXILIAR DE BODEGA

Comercializadora de insumos y material de empaque para el sector farmacéutico requiere personal bachiller o estudiantes de carreras técnicas para trabajar en cargue y descargue de mercancía, manejo de montacarga, gestión de entregas a clientes, atención al usuario, disponibilidad para trabajo en alturas. horario de lunes a viernes de 6:30am a 5pm. zona franca fontibón, salario mínimo legal vigente, más beneficios corporativos. tipo de puesto: tiempo completo salario: $1.000.000 - $1.000.001 al mes consideraciones ante el covid-19: uso tapabocas, protocolos de higiene y desinfección....


(UL-648) - GRADUATE PHARMACOVIGILANCE ASSOCIATE

As a graduate pharmacovigilance associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. you will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. working in this program you will feel challenged and supported to advance in your professional career while making a truly impact. **what you will be doing**: - perform processing for all types of safety events, reconciliation of saes, literature surveillance, data retrievals from the safety database, medical information call handling activities and other medically related project information under mentorship of a drug safety associate or above. - ensure all icon, sponsor, and regulatory timeframes are met for the processing and reporting of safety information - assist in ensuring the completion of all departmental project activities accurately in accordance with icon standards, regulatory requirements, and contractual obligations to sponsors for icon strategic solutions, may also include: - serve as safety reporting processor for assigned projects, providing support as designated. - complete adverse event and/or product quality complaint cases follow up in writing and/or by phone based on requirements for each client. - supports periodic reconciliation of adverse event and/or quality complaint cases received from different sources within the required deadlines - serve as quality complaint processor for assigned projects and monitor the process of retu...


MIDDLE FRONT-END DEVELOPER | (BFZ864)

Our client is a major player in the healthcare industry worldwide. they partner with almost every pharmaceutical and healthcare company in the field, operating across various sectors like research and development, commercial activities, supply chain management, and manufacturing. in essence, the company covers all aspects of the healthcare value chain. our client developed a platform for generative ai in partnership with aws. **responsibilities**: - collaborate with product managers, designers, and backend engineers to understand and translate requirements into technical specifications. - write clean, efficient, and well-documented code. - implement and maintain automated tests to ensure the reliability and stability of the frontend codebase. - stay up-to-date with the latest front-end development trends and technologies. - participate in code reviews and provide constructive feedback to team members. **requirements**: - bachelor's degree in computer science, engineering, or related field. - 3+ years of experience as a frontend engineer, focusing strongly on react and typescript. - solid understanding of html, css, and javascript. - familiarity with restful apis and asynchronous request handling. - proficiency in version control systems (e.g., git). - excellent communication skills and proficiency in english. - ability to work effectively independently and as part of a diverse team. **benefits** - 36 paid absence days per year for the work-life balance of each specialist + 1 additional day for each following year of cooperation with the company - up to...


[Z337] ASISTENTE ADMON ÁREA COMERCIAL

Prestar un servicio de calidad y de apoyo a los clientes externos e internos para reducir las quejas y reclamos. - indagar la solicitud del requerimiento del cliente y dar respuesta inmediata y eficiente de acuerdo al alcance, apoyado en los procesos relacionados. - realizar proceso de corte en sap y solicitar a logística bodega entrega de material para el proceso de adecuación, etiquetado y entrega al cliente. - solicitar tiquetes aéreos y reservas de hotel de acuerdo a itinerario informado; se confirma por medio de correo al asesor comercial. - envío de documentos a gerencia y financiero para realizar análisis financiero y confirmar aprobación de crédito. - solicitud, recepción, validación y archivo de los documentos enviados por los clientes para creación, actualización y reactivación. - seguimiento a liquidaciones, ingresos de material a sap y solicitud de precios para facturar. - instrucción y seguimiento de registros de importación, ica, invima o productos controlados - recepción, revisión, digitalización y entrega al cliente de facturas de importación, exportación, re expedición junto con los demás documentos para los procesos de nacionalización del cliente. - trazabilidad de arribo a bodega de cargas aéreas y marítimas - envío al cliente los documentos de transporte junto con los datos de reserva (sea/ air) para aprobación de despacho previa obtención de los permisos de importación. - atender requerimientos de ventas tipo de puesto: tiempo completo, indefinido salario: $1.300.000 - $1.400.000 al mes consideraciones ante el covid-19: trabajo en casa, a...


ASISTENTE DE COMPRAS K85

Compañía comercializadora de insumos y material de empaque para el sector farmacéutico requiere un tecnólogo en comercio exterior o carreras a fines de negocios internacionales, con experiência de uno a dos años, recién egresado con ganas de aprender, persona proactiva, analítica y buena actitud de servicio, con nível de ingles medio, escrito, para apoyo al proceso de compras. tipo de puesto: tiempo completo salario: $1.300.000 - $1.500.000 al mes consideraciones ante el covid-19: medidas básicas de limpieza y desinfección, uso tapabocas opcional, trabajo en casa...


[MO982] AUXILIAR BODEGA

Manejo de montacarga, recepción almacenamiento y despacho mercancías, cargue y descargue de contenedores, labores de bodega, verificación de mercancía, ubicación y alistamiento de mercancía, reporte de averías, realizar inventarios, identificación cargas ilícitas, limpieza y adecuación de productos a despachar, limpieza y desinfección de áreas. disposición para trabajo en alturas. tipo de puesto: tiempo completo, indefinido salario: $1.000.000 - $1.000.001 al mes consideraciones ante el covid-19: protocolos de limpieza y desinfección...


PHARMACOVIGILANCE ASSOCIATE

full time Tiempo completo

Job title: pharmacovigilance associate job location: bogotá, bogota, colombia job location type: on-site job contract type: permanent job seniority level: home based icon plc is a world-leading healthcare intelligence and clinical research organization. we’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. we are currently seeking a pharmacovigilance associate to join our diverse and dynamic team. as a pharmacovigilance associate at icon, you will play a vital role in monitoring and ensuring the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information. your attention to detail and understanding of regulatory requirements will be essential in supporting the organization’s commitment to patient safety and compliance. what you will be doing: collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines. conducting signal detection and risk assessment activities to identify potential safety issues. collaborating with cross-functional teams to support safety-related inquiries and investigations. maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices. assisting in the preparation of safety reports and regulatory submissions. your profile: bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred. experience in pharmacovigilance, drug safety, or a related area, preferably within a clini...


D912 - ASISTENTE ADMON ÁREA COMERCIAL

Prestar un servicio de calidad y de apoyo a los clientes externos e internos para reducir las quejas y reclamos. - indagar la solicitud del requerimiento del cliente y dar respuesta inmediata y eficiente de acuerdo al alcance, apoyado en los procesos relacionados. - realizar proceso de corte en sap y solicitar a logística bodega entrega de material para el proceso de adecuación, etiquetado y entrega al cliente. - solicitar tiquetes aéreos y reservas de hotel de acuerdo a itinerario informado; se confirma por medio de correo al asesor comercial. - envío de documentos a gerencia y financiero para realizar análisis financiero y confirmar aprobación de crédito. - solicitud, recepción, validación y archivo de los documentos enviados por los clientes para creación, actualización y reactivación. - seguimiento a liquidaciones, ingresos de material a sap y solicitud de precios para facturar. - instrucción y seguimiento de registros de importación, ica, invima o productos controlados - recepción, revisión, digitalización y entrega al cliente de facturas de importación, exportación, re expedición junto con los demás documentos para los procesos de nacionalización del cliente. - trazabilidad de arribo a bodega de cargas aéreas y marítimas - envío al cliente los documentos de transporte junto con los datos de reserva (sea/ air) para aprobación de despacho previa obtención de los permisos de importación. - atender requerimientos de ventas tipo de puesto: tiempo completo, indefinido salario: $1.300.000 - $1.400.000 al mes consideraciones ante el covid-19: trabajo en casa, a...


AUXILIAR BODEGA - (IXB486)

Manejo de montacarga, recepción almacenamiento y despacho mercancías, cargue y descargue de contenedores, labores de bodega, verificación de mercancía, ubicación y alistamiento de mercancía, reporte de averías, realizar inventarios, identificación cargas ilícitas, limpieza y adecuación de productos a despachar, limpieza y desinfección de áreas. disposición para trabajo en alturas. tipo de puesto: tiempo completo, indefinido salario: $1.000.000 - $1.000.001 al mes consideraciones ante el covid-19: protocolos de limpieza y desinfección...


AUXILIAR BODEGA | J-726

Manejo de montacarga, recepción almacenamiento y despacho mercancías, cargue y descargue de contenedores, labores de bodega, verificación de mercancía, ubicación y alistamiento de mercancía, reporte de averías, realizar inventarios, identificación cargas ilícitas, limpieza y adecuación de productos a despachar, limpieza y desinfección de áreas. disposición para trabajo en alturas. tipo de puesto: tiempo completo, indefinido salario: $1.000.000 - $1.000.001 al mes consideraciones ante el covid-19: protocolos de limpieza y desinfección...


(EY115) | CLINICAL DATA LEAD

Icon plc is a world-leading healthcare intelligence and clinical research organization. from molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. with our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. our people are our greatest strength, are at the core of our culture, and the driving force behind our success. icon people have a mission to succeed and a passion that ensures what we do, we do well. we have an incredible opportunity for a **clinical data lead** to join the team. **location**: - mexico (home based - colombia (home based) **overview of the role**: as a clinical data lead (cdl) you will be the point of contact for day to day activity on a study with key responsibilities for study set-up and close-out tasks as well as overseeing and coordinating tasks delegated to the study team members both locally and in other offices. you will also coordinate with data management teams, studies and programs of studies and independently oversee the performance of data management activities on multiple studies. - independently prepare all materials and take part in study kick off (internal and external) meeting. - review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the dmpm and contract analyst. - lead the development of specifications, implementation, and testing for the ecrf or paper crf. ...


CRA II - [SB731]

As a clinical research associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. a cra is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. you will be partnering with one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. this global pharmaceutical client develops breakthrough innovative medicines to improve and extend the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance. **what you will be doing**: - completes onsite and remote monitoring activities in accordance with all ich-gcp guidelines, applicable regulations, sops and study processes - verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations. - ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, gcp, applicable regulations and sops. - writes and submits reports of investigational site findings and updates applicable tracking systems. escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate. - participates in audit preparation and follow-up activities as needed. - may serve as preceptor, providing training to less experienced clinical team members. - may ...


ASSOCIATE DIRECTOR, EXTERNAL AUDITS & INSPECTIONS - (N586)

Under the leadership and directional guidance of the associate director, external audits & inspections management lead, who drives and supports the development and implementation of strategies and initiatives to prepare organon research & development the associate director will support activities related to inspections and external audits for the various b&o; functions related gxps and will partner with cross-functional leads and subject matter experts (smes) to ensure an advanced understanding of health authority perspective and expectations and can help those colleagues understand this mindset. ***this role can be 100% remote in the north america/latam** **responsibilities** - execute the inspection and external audit strategy, facilitating and supporting on-site and remote audits and health authority inspections. inspection experience a plus. - support the global audit and inspection readiness program. - contribute on the development of standard policies and procedures and supporting tools to enable flawless execution in all external audits and inspections. - collaborate with cross-functional teams to ensure all capa commitments related to external audits or inspections are completed on time and determined to be effective. - provide support in establishing and maintaining a compliance governance structure, providing metrics review of key quality & compliance activities. - prioritize and ensure ad hoc and emerging topics are reviewed and escalated in a timely manner. - ensure organon responses to any external audit or inspection report are concise and strateg...


SENIOR CRA

As a clinical research associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. you will be partnering with one of our global pharmaceutical clients; a company that is ...


ESPECIALISTA CALIDAD Y PROCESOS PSP

Iqvia bogota, d. c. capital district, colombia join or sign in to find your next job join to apply for the especialista calidad y procesos psp role at iqvia iqvia bogota, d. c. capital district, colombia join to apply for the especialista calidad y p...


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