Director, Global Pharmacovigilance Operations Lead

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

Why Sarepta? Why Now?

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity.

We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

This position will oversee Sarepta Pharmacovigilance (PV) case management activities globally for assigned investigational and marketed Sarepta products. This position will also lead strategic PV operational projects and initiatives in collaboration with senior PV management, with minimal guidance. The Director, Pharmacovigilance Operations position requires a highly motivated leader with strong operations, analytical, strategic, and critical thinking skills, and ability to consistently deliver results. The incumbent will join the PV department reporting directly to the Executive Director and Head of Pharmacovigilance Operations and Quality Management.

The Opportunity to Make a Difference

Primary Responsibilities Include:

• 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 but not limited to literature reviews, safety data receipt, data entry, case processing, medical evaluation, follow-up, expedited reporting, and closure of Individual Case Safety Reports (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

More about You

Desired Education and Skills:

• 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
• Excellent organizational skills and ability to apply diligence in all aspects of work
• Experience serving as an SME 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
• Project Management (Intermediate)
• Leadership:
  • o Team Leadership: Ability to manage and lead direct reports
  • o Matrix Leadership: Ability to build relationships and influence peers, functional managers, and leaders cross-functionally
• Exhibits attributes congruent with Sarepta Behaviors: Patients First, Action, Unconventional Thinking, Talent, and Integrity
• Global experience is preferred
• Occa