Chief Safety & Pharmacovigilance Officer

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

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics is seeking an Executive Medical Director, SERM to provide leadership for safety scientists and safety physicians in the SERM group. You will own safety, pharmacovigilance, and risk management activities across investigational and marketed products.

You will collaborate with cross-functional teams in a matrix environment, drive medical safety oversight in trials, and contribute to risk management and REMS programs.

Qualifications

• MD with knowledge and clinical practice in General Medicine.
• 7+ years pharmacovigilance experience.
• Experience in safety reviews of clinical safety data and regulatory documents (AEs/SAEs, IBs, protocols, CSR, safety submissions).
• Ability to communicate and collaborate effectively in a matrix environment.

Responsibilities

• Represent PV & RM in clinical development projects providing expert medical guidance on safety matters for investigational products.
• Communicate safety alerts/signals, risk management plans, reference safety information and safety evaluations of emergent safety issues.
• Provide medical safety oversight in clinical trials.
• Lead protocol development for safety data collection, monitoring of safety data, and review of AEs/SAEs.
• Contribute to periodic safety reports (DSUR, EAP, PBRER) and safety governance.
• Lead REMS content development and safety risk management plans.

Skills

Pharmacovigilance

Safety oversight

Medical communication

Clinical safety data review

Multi-tasking

Education

MD / Doctor of Medicine

Job description

Sarepta Therapeutics is seeking an Executive Medical Director, SERM to provide leadership for safety scientists and safety physicians in the SERM group. You will own safety, pharmacovigilance, and risk management activities across investigational and marketed products.

You will collaborate with cross-functional teams in a matrix environment, drive medical safety oversight in trials, and contribute to risk management and REMS programs.