**Title**: Pharmacovigilance Coordinator **Company**: Ipsen Pharma (SAS) - Ensure the proper operation of the Pharmacovigilance System of the affiliate and promote the knowledge on products safety, enabling improvement actions in health care. - Evaluate the product safety related information to meet the demands of the health authorities, the company's needs, and other internal and external customers, in accordance with corporate and local guidelines. - Be the point of contact for Global Patient Safety - Manage the Pharmacovigilance department ensuring the implementation of the activities and the compliance of the areas. Main responsibilities / job expectations **General Items** - Act as the Pharmacovigilance Coordinator and provide support to the PV Department of the Colombian Affiliate - Ensure the compliance with the corporate standards of product safety related to Pharmacovigilance in the Affiliate. - Ensure local Standard Operational Procedures are maintained up to date and aligned with corporate SOPs. - Prepare and modify local SOPs in accordance with the international policies and procedures, as well as local regulations, and provide support to ensure that these procedures and operational flows are respected. **Compliance**: - Update of the Local Adverse Events and Other PV relevant information (OPRI) Control Tracking that guarantees the notification of adverse events within the deadlines established by Global and the Local authorities. - Manage & oversee from the PV standpoint of view the patient Support Program, Market Research Programs and Social Media projects (Patient Data Collection Systems - PDCS) implemented in the country to ensure compliance with PV requirements. - Secure the inclusion of the legal PV requirements as per local laws in all agreements with third parties (distributors, wholesalers, service providers, among others) and monitor the compliance with the established requirements. - Provide support during the preparation or revision of any PV direct contract or PV clauses requiring contracts. **Regulatory Authority** - Adapting global RMPs and PSURs to meet local regulatory requirements. - RMPs and PSURs planning and submission to MOH and regulatory plans for new indications/molecules keeping updated the global tools. - Perform and archive the reconciliations of spontaneous pharmacovigilance reports with Third Party providers as described in the contract according to local laws and regulations. - Carry out the processes to properly document any deviation in the procedures. - Carry out the notification of adverse events to Local Regulatory Authorities in accordance with local laws/requirements and within the stablished deadlines in them. **Adverse Event Processing** - Processing, notification, monitoring of spontaneous/requested and clinical adverse events for GPV in accordance with the requirements of international and local procedures. - Conduction of a search in the literature in the local language (not included in the search performed by GPV) to identify adverse events involving Ipsen products and notify GPV according with the requirements established in international procedures. - Ensure that patient confidentiality (data privacy policy) is respected in accordance with local requirements in handling adverse events before notifying the GPV. - Screening in the local literature and social media of adverse events involving locally approved IPSEN products. - Ensure compliance and monitoring of the periodic reconciliation process. - Ensure the achievement of the reconciliation of spontaneous pharmacovigilance reports with partners as provided in the contract. **Technical complaints and Medical Information** - Review of technical complaints through the reconciliation of Technical Complains, ensuring that all adverse events are reported to GPV and local authorities. - Provide support to Medical Information and Product Complaint teams to ensure the receipt, management, follow up, and tracking of safety reports from all sources and its proper forwarding to the Ipsen Global Patient Safety (GPS) Case Processing Center for entry into the global safety database. **Trainings** - Training to involved personnel of all programs in the identification and adequate reporting of adverse events. - Monitoring and training of the vendors or involved personnel to ensure the compliance of all the PV requirements. - Provide support during the annual pharmacovigilance training to the Colombian affiliate employees and keep the training documentation updated. - Ensure an appropriate pharmacovigilance training to any partner, as provided in the contract, and keep the documentation updated.