Medical Director, Pharmacovigilance - Safety Science
San Mateo Metro Area, California
- Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting.
- Assist in follow-up of important ICSRs to ensure relevant information is sought.
- Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals.
- Participate in the development of safety surveillance and risk management plans for drug development programs.
- Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report).
- Serve as Safety Management Team Leader and liaise with clinical study/project teams, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees and other entities as needed.
- Provide safety advice and inform Pharmacovigilance senior management as appropriate.
- Participate in the preparation and revision of company product labeling and RMP as appropriate.
- Collaborate with Medical Directors in both Clinical Development and Medical Affairs to provide expertise in both US and ex-US post-marketing safety surveillance requirements (e.g., registries).
- Review and advise on safety/medical information in advertising and promotional materials as needed.
- Help prepare and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other
- Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements.
- Minimum 5 years experience in PV with specific drug safety science experience.
- Excellent medical knowledge with the ability to interpret, synthesize and communicate complex medical/pharmaceutical information and safety data to both healthcare professionals (HCPs) and non-HCPs.
- Experience reviewing cumulative safety data.
- Strong working knowledge of US and ex-US PV requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines).
- Experience with pre- and post-marketing ICSR processing and aggregate safety reporting.
- Knowledge of MedDRA terminology and its application.
- Experience in the preparation of PSURs, Pharmacovigilance Plans, Risk Management Plans, and Reference Safety Information.
- Experience in safety issue/signal management.
- Thorough understanding of the drug development process and context applicable to safety surveillance.
- Excellent verbal and written communication skills, including formal presentations.
- Sound organizational skills with the ability to prioritize tasks.
- Excellent interpersonal, team management and leadership skills.
- Proficiency in Word, Excel, and safety databases.
- Medical degree (e.g., MD, DO) with the appropriate clinical and pharmacovigilance experience.