Director, Global Pharmacovigilance Operations

The Director, Global Pharmacovigilance Operations will oversee Sarepta Pharmacovigilance (PV) case management activities globally for assigned investigational and marketed products and lead strategic PV operational projects with minimal guidance.

Responsibilities:
- Lead pharmacovigilance operations and deliver high PV ICSR quality control for intake, case management, safety reporting, and follow-up
- Oversee PV vendor case management (literature reviews, safety data receipt, data entry, case processing, medical evaluation, follow-up, expedited reporting, and ICSR closure)
- Support risk management (contribute to development of risk documents such as RMPs/RARs; perform QC upon request)
- Conduct functional review of study protocols and escalate challenges/issues
- Manage discussions with license partners to ensure efficiency, compliance, and continuous improvement
- Develop and maintain Pharmacovigilance Agreements (PVAs)
- Review and provide input to EDC CRFs and Safety Gateway projects
- Lead creation/implementation of safety reporting plans, data entry conventions, and SOPs
- Execute PV operational activities for regulatory filings and product registrations
- Collaborate cross-functionally (Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal, Commercial)
- Lead weekly case review meetings and guide resolution of actions
- Review product complaints
- Identify/analyze/develop/implement continuous improvement opportunities for PV processes and systems
- Delegate for Head of Global Pharmacovigilance Operations, Quality Management, and Safety Systems upon request

Qualifications:
- Advanced degree in Biological Sciences, Nursing, or Healthcare administration
- 12+ years of related professional experience
- Advanced Argus experience
- Advanced knowledge of drug development
- Advanced knowledge of global PV regulations/guidelines (FDA, EMA, ICH)
- MedDRA (Intermediate)
- Process mapping (Intermediate)
- Project Management (Intermediate)
- Team leadership and matrix leadership
- Experience as an SME in audits and inspections
- Global experience preferred; occasional travel may be required

Skills:
- Excellent written and verbal communication skills (team and cross-functional)
- Excellent organizational skills and diligence
- Strong operations, analytical, strategic, and critical thinking skills
- Intermediate MS Office skills
- Ability to manage multiple products/platform-level
- High learning agility

Benefits:
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers

Application instructions:
- Candidates should apply if comfortable with ambiguity and candor and committed to patients.