Senior Medical Director, Safety & Pharmacovigilance

Sarepta Therapeutics; Cambridge (MA); Hybrid; USD 313,000 - 392,000; Full time

Job summary

Sarepta Therapeutics, headquartered in the United States, seeks an Executive Medical Director, SERM to lead safety scientists and safety physicians within PV & RM. You will own safety, pharmacovigilance, and risk management for investigational and marketed products, working across matrix teams in a hybrid setup.

Responsibilities include medical safety oversight in trials, contributing to safety communications, DSUR/PBRER activities, REMS planning, and safety governance.

Qualifications

• MD with solid knowledge and clinical practice in general medicine.
• 7+ years pharmacovigilance experience in clinical trials and post-marketing.
• Familiarity with GVP, GCP, ICH guidance and safety regulations.

Responsibilities

• Provide leadership for PV & RM safety in the SERM group and clinical development projects.
• Oversee safety reviews, ADEs/SAEs, and safety data monitoring across trials.
• Lead preparation of DSUR, PBRER, and safety submissions (CTD safety summary).
• Collaborate across matrix teams including Regulatory, Clinical and QA.

Skills

Pharmacovigilance

Safety signal evaluation

DSUR/PBRER knowledge

ICSRs handling

Regulatory compliance

Communication skills

Team collaboration

Education

MD

Job description

Sarepta Therapeutics, headquartered in the United States, seeks an Executive Medical Director, SERM to lead safety scientists and safety physicians within PV & RM. You will own safety, pharmacovigilance, and risk management for investigational and marketed products, working across matrix teams in a hybrid setup.

Responsibilities include medical safety oversight in trials, contributing to safety communications, DSUR/PBRER activities, REMS planning, and safety governance.