Director, Global Pharmacovigilance Operations Lead

Sarepta Therapeutics • Cambridge, MA

1d • Hybrid

About The Position

The Director, Global Pharmacovigilance Operations Lead oversees global pharmacovigilance (PV) case management for assigned investigational and marketed Sarepta products. The role also leads strategic PV operational projects and initiatives in collaboration with senior PV management, with minimal guidance. The Director is a highly motivated leader who applies strong operational, analytical, strategic, and critical-thinking skills to deliver results. The position is part of the PV department and reports directly to the Executive Director and Head of Pharmacovigilance Operations and Quality Management.

The role leads PV operations and case quality, oversees vendor case management, supports risk management, reviews study protocols, and manages PV relationships and agreements with license partners. It also develops safety reporting plans and procedures, supports regulatory filings and product registrations, collaborates across functions, leads case review meetings, and drives continuous improvement across PV processes and systems. Occasional travel may be required. The position is hybrid, with expected onsite work at a Sarepta facility in the United States and/or attendance at company-sponsored in-person events from time to time. Candidates must be authorized to work in the U.S.

Requirements

• Advanced degree in Biological Sciences, Nursing, or Healthcare Administration.
• 12 or more years of related professional experience.
• Advanced Argus experience.
• Advanced knowledge of drug development.
• Advanced knowledge of global PV regulations and guidelines, including FDA, EMA, and ICH.
• Intermediate MS Office skills.
• Intermediate MedDRA skills.
• Advanced ability to manage multiple products or work at a platform level.
• Intermediate process-mapping skills.
• Excellent written and verbal communication skills at team and cross-functional levels.
• Excellent organizational skills and diligence in all aspects of work.
• Experience serving as a subject matter expert in audits and inspections.
• High learning agility.
• Ability to collaborate with and influence peers, subordinates, senior leaders, vendors, and business partners.
• Ability to enhance the knowledge of peers, subordinates, and senior leaders.
• Intermediate project-management skills.
• Team leadership ability, including managing and leading direct reports.
• Matrix leadership ability, including building relationships and influencing peers, functional managers, and cross-functional leaders.
• Attributes congruent with Sarepta Behaviors: Patients First, Action, Unconventional Thinking, Talent, and Integrity.
• Authorization to work in the United States.

Nice To Haves

• Global experience.
• Occasional travel may be required.

Responsibilities

• Lead pharmacovigilance operations for assigned products and deliver high-quality PV ICSR quality control for intake, case management, safety reporting, and follow-up.
• Oversee PV vendor case management activities for assigned products, including literature reviews, safety data receipt, data entry, case processing, medical evaluation, follow-up, expedited reporting, and ICSR closure.
• Provide operational support for risk management, contribute to risk documents such as RMPs and RARs, and perform quality control of these documents when requested.
• Conduct functional reviews of study protocols and escalate challenges or issues for resolution.
• Manage direct discussions with license partners to support efficiency, compliance, and continuous improvement.
• Develop and maintain Pharmacovigilance Agreements with license partners.
• Review and provide input to EDC CRFs and Safety Gateway projects.
• Lead creation and implementation of safety reporting plans, data-entry conventions, and standard operating procedures.
• Execute PV operational activities for regulatory filings and product registrations.
• Collaborate with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal, and Commercial to implement Sarepta PV processes.
• Lead weekly case review meetings and guide resolution of resulting actions.
• Review product complaints for assigned products.
• Identify, analyze, develop, and implement continuous improvement opportunities for PV operations processes and systems.
• Serve as delegate for the Head of Pharmacovigilance Operations and Quality Management upon request.

Benefits

• Competitive compensation and benefit package.
• Benefits and work-life resources supporting physical and emotional wellness, financial wellness, and caregivers.

What This Job Offers

• Job Type: Full-time
• Career Level: Director