Director, Global Pharmacovigilance Operations Lead

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

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.

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:
  • Team Leadership: Ability to manage and lead direct reports
  • 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
• Occasional travel may be required

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

What Now?

We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.

The targeted salary range for this position is $185,600 - $232,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.

Users must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

Sarepta is on an urgent mission

Engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy.

For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.