Director, Patient Safety (MD)
Gilead Sciences
August 08, 2026
Remote friendly (San Francisco Bay Area)
United States
Medical Affairs
Summary
- Provide medical leadership and oversight of individual case safety report review activities across marketed and investigational products.
- Deliver timely, high-quality medical safety assessments supporting patient safety, benefit-risk evaluation, and regulatory compliance.
- Lead efforts to advance quality, consistency, and effectiveness of Medical Review activities (including peer retrospective medical review quality control), and refine medical review processes, standards, practices, efficiencies, and capabilities.
- Serve as a medical review subject matter expert providing consultation and strategic guidance to cross-functional partners.
Key Responsibilities
- Provide expert medical safety assessment for individual cases and line listings.
- Perform peer retrospective medical review quality control.
- Respond to medical review questions from other functions in a timely manner.
- Collaborate on assessment and communication of suspected unexpected, serious adverse reactions (SUSARs) reports.
- Provide ad hoc medical consultation to Literature Management, Coding Strategy, and Auto labeling Management.
- Contribute to development/refinement of medical review processes; may lead or maintain procedural documents and provide training.
- Support internal/external audits and inspections; participate in educational initiatives.
- Drive process improvements in adverse event processing/operational aspects.
- Initiate/lead/contribute to functional or cross-functional projects.
- Ensure work complies with practices, policies, processes, and regulatory/other requirements.
- Mentor and train junior staff/new hires/contractors to independently review adverse event reports.
Basic Qualifications
- MD/DO degree or equivalent.
Preferred Qualifications
- Completed accredited medical/surgical residency program; board certification preferred.
- 4+ years’ experience in medical review OR applicable pharmaceutical industry role with strong knowledge of global regulatory requirements.
- Strong scientific/clinical/analytical knowledge; exceptional communication, collaboration, and project management skills; high attention to detail, scientific rigor, proactive solutions mindset.
Application Instructions
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.
- Provide medical leadership and oversight of individual case safety report review activities across marketed and investigational products.
- Deliver timely, high-quality medical safety assessments supporting patient safety, benefit-risk evaluation, and regulatory compliance.
- Lead efforts to advance quality, consistency, and effectiveness of Medical Review activities (including peer retrospective medical review quality control), and refine medical review processes, standards, practices, efficiencies, and capabilities.
- Serve as a medical review subject matter expert providing consultation and strategic guidance to cross-functional partners.
Key Responsibilities
- Provide expert medical safety assessment for individual cases and line listings.
- Perform peer retrospective medical review quality control.
- Respond to medical review questions from other functions in a timely manner.
- Collaborate on assessment and communication of suspected unexpected, serious adverse reactions (SUSARs) reports.
- Provide ad hoc medical consultation to Literature Management, Coding Strategy, and Auto labeling Management.
- Contribute to development/refinement of medical review processes; may lead or maintain procedural documents and provide training.
- Support internal/external audits and inspections; participate in educational initiatives.
- Drive process improvements in adverse event processing/operational aspects.
- Initiate/lead/contribute to functional or cross-functional projects.
- Ensure work complies with practices, policies, processes, and regulatory/other requirements.
- Mentor and train junior staff/new hires/contractors to independently review adverse event reports.
Basic Qualifications
- MD/DO degree or equivalent.
Preferred Qualifications
- Completed accredited medical/surgical residency program; board certification preferred.
- 4+ years’ experience in medical review OR applicable pharmaceutical industry role with strong knowledge of global regulatory requirements.
- Strong scientific/clinical/analytical knowledge; exceptional communication, collaboration, and project management skills; high attention to detail, scientific rigor, proactive solutions mindset.
Application Instructions
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.