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Medical Director, Pharmacovigilance

  • Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving BioMarin 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 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.
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