Job Description

The role of Executive Director/VP for Safety and Pharmacovigilance encompasses full-spectrum oversight of safety operations, spanning both clinical and commercial drug safety for all company compounds. The ideal candidate will spearhead the safety department, collaborating within a multifaceted team consisting of clinical, regulatory, scientific, biometrics, operational, and commercial professionals. They will also liaise with external experts, vendors, government agencies, and investigators. This role necessitates strategic leadership in steering the company’s pharmacovigilance and safety endeavors, extending to future compound developments.

Primary Responsibilities

• Assume responsibility for all medical safety aspects concerning the clinical development and post-market surveillance of medicinal products within the company's portfolio.
• Take charge of both medical safety and safety operations for both clinical and commercial compounds.
• Oversee vendor deliverables and performance metrics related to safety and pharmacovigilance in clinical programs, as well as approved products.
• Provide strategic oversight and global responsibility for commercial safety reporting mandates in the US, EU, and other international regions, as deemed necessary.
• Manage, supervise, and mentor a team while maintaining a strategic and forward-looking approach to team development and planning.
• Collaborate with clinical development representatives to lead safety signal assessments and validate safety signals.
• Engage in interactions with health authorities (written and verbal) and participate in inspections related to safety risk management; potentially overseeing a team member assisting in such interactions.
• Supervise Drug Safety Committees and Core Safety Information.
• Lead the safety strategy for regulatory communications and oversee support activities for submission processes.
• Contribute written summaries and perform safety reviews for components such as protocols, Investigator's Brochures (IB), clinical study reports, regulatory submissions, label negotiations, and more by collaborating directly with team members and providing tactical support as needed.
• Oversee, compose, or review periodic aggregate/safety reports.
• Manage Case Processing and conduct Medical Review of SUSARs (Suspected Unexpected Serious Adverse Reactions) and CSR (Clinical Study Report) Narrative reviews, along with follow-ups with site investigators.
• Conduct Benefit-Risk Assessments in collaboration with the Clinical Development team when required.
• Ensure compliance with global safety standards and maintain readiness for inspections, including conducting root-cause analyses.
• Foster and maintain relationships with clients and team members while providing expert safety insights and guidance.

Qualifications:

• A minimum qualification of an MD or PharmD, combined with pertinent safety and pharmacovigilance (PV) experience gained within biotech or pharma
• Applicants should possess a background in team development, including direct or matrixed team leadership, and a history of guiding projects to successful completion.
• Demonstrated experience in crafting risk management and signal detection strategies is essential, as well as a comprehensive understanding of global pharmacovigilance requirements.
• Candidates must have prior experience in supervising safety and PV service providers and be familiar with regulatory authority inspections.
• The ability to formulate robust safety strategies at a strategic level, alongside the capability to execute detailed work in support of Phase 1-3 programs and commercial product endeavors, is also a fundamental requirement.

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