Global PV Operations Director — Strategic Impact Leader

Sarepta Therapeutics; Cambridge (MA); Hybrid; USD 186,000 - 232,000; Full time

Job summary

Sarepta Therapeutics is seeking a Director, Pharmacovigilance Operations to lead global PV case management for assigned products and drive strategic PV projects. You will collaborate with senior PV leadership to deliver high-quality safety data and regulatory submissions.

Hybrid work in the United States; extensive cross-functional engagement across Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal and Commercial; strong leadership and Global PV

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 and guidelines including FDA, EMA, and ICH.
• Intermediate MS Office skills.
• MedDRA (Intermediate).
• Advanced ability to manage multiple products or at platform-level.
• Process mapping (Intermediate).
• Excellent written and verbal communication skills at team and cross-functional levels.

Responsibilities

• Lead pharmacovigilance operations for assigned products and deliver high PV ICSR quality control for intake, case management, safety reporting and follow-up.
• Oversee 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 closure of ICSRs.
• Provide operational support for risk management including contributions to development of risk documents (e.g., RMPs, RARs, etc.) and perform QC of such documents upon request.
• Conduct functional review of study protocols and elevate challenges/issues for resolution.
• Manage and maintain direct discussions with license partners to ensure efficiency, compliance, and continuous improvement.
• Develop and maintain Pharmacovigilance Agreements (PVAs) 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 cross-functionally with Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal and Commercial in implementing Sarepta PV processes.
• Lead weekly case review meetings and guide resolution of ensuing actions.
• Review product complaints for assigned products.
• Identify, analyze, develop, and implement continuous improvement opportunities for Sarepta PV operations processes and systems.
• Delegate for the Head of Pharmacovigilance Operations and Quality Management, upon request.

Skills

Argus expertise

PV regulations

Drug development knowledge

Global PV

Project management

Leadership

Communication skills

Audits/Inspections

Cross-functional collaboration

Travel readiness

Education

Advanced degree in Biomedical sciences

Tools

MS Office

MedDRA

Regulatory databases

Job description

Sarepta Therapeutics is seeking a Director, Pharmacovigilance Operations to lead global PV case management for assigned products and drive strategic PV projects. You will collaborate with senior PV leadership to deliver high-quality safety data and regulatory submissions.

Hybrid work in the United States; extensive cross-functional engagement across Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal and Commercial; strong leadership and Global PV