Director, Global Pharmacovigilance Operations Lead
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, and requires strong operational, analytical, strategic, and critical-thinking skills. The position is part of the PV department and reports directly to the Executive Director and Head of Pharmacovigilance Operations and Quality Management. 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. Occasional travel may be required. Candidates must be authorized to work in the United States.
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 with 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.
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 the PV vendor’s 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, including contributing to risk documents such as RMPs and RARs and performing quality control of those documents upon request.
- Conduct functional reviews of study protocols and escalate challenges or issues for resolution.
- Manage and maintain direct discussions with license partners to ensure 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 the 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 cross-functionally 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.
- Work-life resources intended to support physical and emotional wellness, financial wellness, and caregivers.
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What This Job Offers
Job Type
Full-time
Career Level
Director
