Director, Patient Safety (MD)
About The Position
We are seeking a highly motivated and strategic Patient Safety Medical Review Physician (MD) to provide medical leadership and oversight of individual case safety report review activities across marketed and investigational products. This role is critical to delivering timely, high-quality medical safety assessments that support patient safety, informed benefit-risk evaluation, and regulatory compliance. The Director will serve as a recognized expert in medical safety assessment and play a key leadership role in advancing the quality, consistency, and effectiveness of Medical Review activities. This includes overseeing peer retrospective medical review quality control (MRQC) activities, supporting audits and inspections, and driving the continued development and refinement of medical review processes, standards, practices, efficiencies, and capabilities. As a medical review subject matter expert, the Director will provide medical consultation and strategic guidance to cross-functional partners. The successful candidate will bring strong clinical judgment, leadership presence, and communication skills, with a demonstrated ability to influence stakeholders, lead initiatives, and collaborate effectively across teams in a dynamic, fast-paced, and deadline-driven environment.
Requirements
- An MD/DO degree or equivalent.
Nice To Haves
- Completion of an accredited medical or surgical residency program. Board certification is preferred.
- minimum of 4 years’ experience in medical review or OR an applicable role in the pharmaceutical industry with strong knowledge of global regulatory requirements.
- Excellent scientific, clinical, and analytical knowledge base, with ability to assess individual case safety reports and understand the safety/medical implications.
- Exceptional communication, collaboration, and project management skills.
- High attention to detail, scientific rigor, and a proactive, solutions-oriented mindset.
Responsibilities
- Establishes recognition as an expert on medical safety assessment of individual cases and line listings.
- Performs peer retrospective medical review quality control activities.
- Responds to medical review-related questions from other functions in a timely manner.
- Collaborates with global safety leads and global safety strategy leads in assessment and communication of suspected unexpected, serious adverse reactions (SUSARs) reports from clinical trials.
- Provides medical consultation to Patient Safety Strategic Operations functional groups including Literature Management, Coding Strategy, and Auto labeling Management on an ad hoc basis.
- Makes significant contributions to the ongoing development and refinement of medical review processes, standards, practices, efficiencies, and capabilities.
- May lead or contribute to develop and maintain procedural document for medical review activities and provide training.
- Supports internal and external audit and inspection.
- Participates in both internal and external educational initiatives.
- Makes contributions to process improvement within Patient Safety, particularly with adverse event processing and operational aspects.
- Initiates, leads, or contributes to functional or cross-functional projects.
- Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
- Provides mentorship and trains junior staff, new hires, and contractors to independently review adverse event reports for investigational and marketed products.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
