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

Developing Advanced Skills

• Growing ability to interpret biomarker data in safety contexts
• Increasing fa