Director, Global Pharmacovigilance Operations

Sarepta Therapeutics • Cambridge, MA

9h • Hybrid

About The Position

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, Global 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 Global PV department reporting directly to the Senior Director, Global Pharmacovigilance Operations.

Requirements

• 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)
• 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’s Cultural Values: Patient Mission, Scientific Rigor, Simplicity, Bias to Action, One Sarepta and Trust
• Candidates must be authorized to work in the U.S.

Nice To Haves

• Global experience is preferred

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 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 escalate 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 Global Pharmacovigilance Operations, Quality Management, and Safety Systems upon request

Benefits

• 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
• Sarepta Therapeutics offers a competitive compensation and benefit package.

What This Job Offers

• Job Type: Full-time
• Career Level: Director