Global PV Operations Director: Drive Safety Excellence

sarepta; Cambridge (MA); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Caregiver support

Job summary

Sarepta Therapeutics seeks an experienced leader to oversee global pharmacovigilance case management and drive PV operations strategy. This role reports to the Executive Director and partners with senior PV management to deliver high-quality safety data for both investigational and marketed products.

Ideal candidates have 12+ years in PV, advanced Argus experience, and a proven ability to lead cross-functional teams across regulatory, clinical, and quality functions.

Qualifications

• Advanced degree in Biological Sciences, Nursing, or Healthcare administration.
• 12+ years of related professional experience.
• Advanced Argus experience.
• Advanced knowledge of global PV regulations and guidelines (FDA, EMA, ICH).
• Experience serving as SME in audits and inspections.

Responsibilities

• Lead pharmacovigilance operations for assigned products and ensure PV ICSR quality for intake, case management, safety reporting and follow-up.
• Oversee PV vendor case management activities including literature reviews, safety data receipt, data entry, case processing, medical evaluation, follow-up, and expedited reporting.
• Provide operational support for risk management documents (RMPs, RARs) and QC of such documents.
• Review study protocols and escalate challenges for resolution.
• Manage discussions with license partners to ensure efficiency and compliance.
• Develop and maintain Pharmacovigilance Agreements (PVAs) with license partners.
• Review input to EDC CRFs and Safety Gateway projects.
• Lead creation and implementation of safety reporting plans and SOPs.
• Execute PV operational activities for regulatory filings and product registrations.
• Collaborate cross-functionally with Clinical Development, Regulatory Affairs, QA, Medical Affairs, Manufacturing, Legal and Commercial.
• Lead weekly case review meetings and drive follow-up actions.
• Review product complaints for assigned products.
• Identify and implement continuous improvement opportunities for Sarepta PV operations processes.

Skills

PV operations leadership

ICSR case management

Vendor management

Cross-functional collaboration

Regulatory compliance

Leadership

Education

Advanced degree in Biological Sciences, Nursing, or Healthcare administration

Tools

Argus Safety

MS Office

Job description

Sarepta Therapeutics seeks an experienced leader to oversee global pharmacovigilance case management and drive PV operations strategy. This role reports to the Executive Director and partners with senior PV management to deliver high-quality safety data for both investigational and marketed products.

Ideal candidates have 12+ years in PV, advanced Argus experience, and a proven ability to lead cross-functional teams across regulatory, clinical, and quality functions.