Medical Director Safety Science

Job Description Job Title:Medical Director, Safety Science Department:Patient Safety Reports to:Applicable Safety Science Manager/Leader Location:United States (San Rafael, CA); Open to hybrid ROLE SUMMARY The Medical Director of Safety Science serves as a key medical expert for our safety surveillance activities, providing medical leadership for assigned products within our portfolio. You will implement pharmacovigilance (PV) strategies, conduct medical safety evaluations, support safety-related regulatory activities, and contribute to the advancement of safety monitoring practices. This role combines clinical expertise with regulatory knowledge to ensure patient safety while supporting business objectives. KEY RESPONSIBILITIES Medical Safety Oversight Serve as a safety physician for assigned products, providing medical expertise during product development and post-market phases Conduct safety signal detection, evaluation, and assessment activities Review and evaluate individual case safety reports (ICSRs), including serious adverse events Provide medical interpretation of safety data and support causality assessments Participate in safety review committees and cross-functional safety meetings Strategic Safety Implementation Implement pharmacovigilance strategies for assigned products under senior guidance Support the development of risk management plans and risk minimization measures Contribute to benefit-risk assessments and support evidence-based safety decisions Work with clinical development teams on safety monitoring activities Support the preparation of safety sections for regulatory submissions Regulatory Support and Documentation Contribute to aggregate safety reports (PSURs/PBRERs, DSURs, RMPs) Support regulatory authority interactions on safety matters Assist in safety-related product labeling activities Support responses to health authority safety queries Ensure adherence to global pharmacovigilance regulations and guidelines Team Collaboration and Mentoring Provide medical guidance to junior PV staff and cross-functional colleagues Support the mentoring of Associate Medical Directors and PV scientists Contribute to the development and review of standard operating procedures Support continuous improvement projects within the PV department Collaborate with regional affiliates on safety activities Scientific Contribution Stay current with evolving safety methodologies and regulatory developments Support company representation at scientific conferences and industry meetings Contribute to scientific publications related to product safety Collaborate with epidemiology teams on post-market safety studies Support implementation of innovative safety assessment approaches QUALIFICATIONS Education and Experience You hold an MD or equivalent medical qualification (active license to practice preferable but not required) You bring 5-8 years of pharmaceutical industry PV experience You have exposure to regulatory authority interactions Technical Knowledge Strong knowledge of global PV regulations and regulatory trends Ability to apply statistical methods for safety data interpretation Understanding of signal detection processes and quantitative PV approaches Knowledge of benefit-risk assessment principles and risk evaluation methods DevelopingAdvanced Skills Growing ability to interpret biomarker data in safety contexts Increasing familiarity with real-world data applications in safety Developing skills in communicating safety concepts to various audiences Basic data visualization capabilities for safety information Understanding of pharmacoepidemiology study principles Professional Capabilities Ability to communicate effectively with management on safety issues Experience supporting product safety activities during launches Capability to work effectively in cross-functional safety teams Understanding of how to balance safety and business considerations Commitment to developing safety science expertise Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. The salary range for this position is: $220,000 to $330,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: https://careers.biomarin.com/benefits.

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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