Job summary The Sr. Scientist Drug Safety will perform in line medical safety review of individual case safety reports ICSR reports and other AE reports of interest Qualifications - Advanced/Graduate degree in nursing e.g. MSN CRNP PharmD Physician's Assistant M.D./D.O. or equivalent degree in Medicine other relevant clinical health related field undergraduate training is flexible with an advance degree in a clinical discipline Responsibilities - As required per SOP and in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead performs adverse experience reports review from specified sources in the safety database for regulatory reporting purposes - Apply knowledge of safety profiles for the adverse experience reports review - Develop working knowledge of pharmacovilance and regulatory reporting of ICSRs - Consult with the ICMR Physician/Management and/or Therapeutic Area Team lead for cases requiring additional clinical or safety subject matter expertise - May perform medical review of other reports of adverse events as required in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead - May perform ICSR follow up activities in conjunction with the ICMR Physician/Management and/or Therapeutic Area Team lead - May participate in process quality innovation technology and other business-related activities under the guidance of ICMR Physician/Management - May participate on special projects or rotational assignments within or outside of ICMR Skills - At least two years of clinical pharmaceutical industry or related experience - Clinically relevant medical experience - The candidate must have strong understanding of scientific and medical concepts - Excellent writing and communication skills in English - Effective presentation skills and experience influencing and negotiating - Computer skills use of database and basic MS Office suite applications - Problem solving conflict resolution and critical thinking skills Desired requirements - Experience in drug safety pharmacovigilance and/or risk management is highly desirable - Prior medical review and/or case management experience - Relevant Safety Systems Experience - Drug development experience early or late phase clinical research regulatory affairs and/or safety/PV Benefits - Regular - Flexible Work Arrangements - Hybrid Descripción del trabajo Lorem ipsum dolor sit amet , consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare. Donec lacinia nisi nec odio ultricies imperdiet. Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula. Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit , at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus. Obtén acceso completo Accede a todos los puestos de alto nivel y consigue el trabajo de tus sueños. Inscríbete ahora