Sr. Medical Director, Drug Safety & Pharmacovigilance
Scholar Rock
August 10, 2026
Remote friendly (Cambridge, MA)
United States
Medical Affairs
Summary of Position:
- Sr. Medical Director, Drug Safety & Pharmacovigilance provides safety strategy and expertise pre- and post-approval for assigned products; proactively implements risk management initiatives; continuously evaluates safety data, performs signal detection, and manages the safety profile; partners with cross-functional teams to meet project goals.
Position Responsibilities:
- Lead/support development of pharmacovigilance strategies for therapeutic area products.
- Oversee and conduct signal detection (monitoring, evaluation, interpretation, management, and communication of safety information).
- Oversee Product Safety Committee (PSC) meetings; evaluate risk-benefit; escalate/present safety issues to the Executive Safety Committee.
- Perform medical safety reviews and causality assessments across preclinical, clinical, post-marketing, and literature sources.
- Provide medical expert input to critical regulatory/clinical documents (e.g., IND/NDA/BLA submissions, protocols/amendments, ICFs, IBs, CSRs).
- Oversee aggregate reports and signal evaluation reports.
- Draft clinical content for regulatory inquiry responses related to safety topics.
- Lead/support CRO staff and ensure vendor oversight of outsourced medical activities.
- Oversee/collaborate with internal safety scientists within therapeutic area.
- Assist with writing/developing SOPs for regulatory/local law compliance.
- Plan and execute external/internal stakeholder meetings (e.g., DMCs, vendor oversight meetings).
Candidate Requirements:
- MD/MBBS/MD-PhD or equivalent.
- 5+ years pharmaceutical Drug Safety & Pharmacovigilance experience.
- Strong US/EU pharmacovigilance regulatory knowledge.
- Experience supporting drug safety in registrational clinical studies.
- Sound knowledge of drug development (discovery to registration) and post-marketing requirements/surveillance.
- Prior IND and NDA/BLA submission/interaction experience highly desirable.
Skills/Abilities:
- Scientific analysis/reasoning; leadership in matrix; ability to translate data into clinical strategies; strong organizational, presentation, and interpersonal skills.
Compensation:
- $280,000 - $420,000 a year.
- Sr. Medical Director, Drug Safety & Pharmacovigilance provides safety strategy and expertise pre- and post-approval for assigned products; proactively implements risk management initiatives; continuously evaluates safety data, performs signal detection, and manages the safety profile; partners with cross-functional teams to meet project goals.
Position Responsibilities:
- Lead/support development of pharmacovigilance strategies for therapeutic area products.
- Oversee and conduct signal detection (monitoring, evaluation, interpretation, management, and communication of safety information).
- Oversee Product Safety Committee (PSC) meetings; evaluate risk-benefit; escalate/present safety issues to the Executive Safety Committee.
- Perform medical safety reviews and causality assessments across preclinical, clinical, post-marketing, and literature sources.
- Provide medical expert input to critical regulatory/clinical documents (e.g., IND/NDA/BLA submissions, protocols/amendments, ICFs, IBs, CSRs).
- Oversee aggregate reports and signal evaluation reports.
- Draft clinical content for regulatory inquiry responses related to safety topics.
- Lead/support CRO staff and ensure vendor oversight of outsourced medical activities.
- Oversee/collaborate with internal safety scientists within therapeutic area.
- Assist with writing/developing SOPs for regulatory/local law compliance.
- Plan and execute external/internal stakeholder meetings (e.g., DMCs, vendor oversight meetings).
Candidate Requirements:
- MD/MBBS/MD-PhD or equivalent.
- 5+ years pharmaceutical Drug Safety & Pharmacovigilance experience.
- Strong US/EU pharmacovigilance regulatory knowledge.
- Experience supporting drug safety in registrational clinical studies.
- Sound knowledge of drug development (discovery to registration) and post-marketing requirements/surveillance.
- Prior IND and NDA/BLA submission/interaction experience highly desirable.
Skills/Abilities:
- Scientific analysis/reasoning; leadership in matrix; ability to translate data into clinical strategies; strong organizational, presentation, and interpersonal skills.
Compensation:
- $280,000 - $420,000 a year.