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Associate / Medical Director, Drug Safety Surveillance (Rare Disease)

Location Brisbane, California

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. 

BioMarin's Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients' lives.

SUMMARY:

The Medical Director, Drug Safety Surveillance is responsible for strategic leadership and medical oversight of BioMarin PV (BPV) activities in collaboration with the EU Qualified Person for PV (EU QPPV), BPV colleagues, and applicable cross-functional specialists, with special focus on identification, evaluation and management of safety risks throughout BioMarin products lifecycle.


RESPONSIBILITIES:

  • 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.


EXPERIENCE:

Required Skills:

  • Minimum 2+ years experience in PV with specific drug safety operational 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.

Desired Skills:

  • Prior international pharmaceutical company experience preferred.

EDUCATION:

  • Medical degree (e.g., MD, DO, Pharm D.) with the appropriate clinical and pharmacovigilance

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