Executive Director, Drug Safety and Pharmacovigilance

Role Summary

Executive Director, Drug Safety and Pharmacovigilance – oversee all aspects of product safety across clinical development and post-marketing surveillance, support safety strategy and regulatory alignment, and lead safety science to protect patient health and optimize product benefit-risk profiles.

Responsibilities

• Develop strategies, with the Head of Safety, to achieve PV Medical Safety goals.
• Represent PV in communications with health authorities (e.g., FDA) alongside the Head of Safety.
• Assess safety signals and trends and proactively manage potential safety issues.
• Formulate response strategies and author responses for health authority requests.
• Determine the need for pharmacoepidemiology, including liaising with external experts.
• Ensure PV Medical Safety activities comply with regulations and company standards.
• Oversee vendors performing medical review of ICSRs and aggregate reports.
• Perform medical review of serious adverse events from clinical trials.
• Evaluate and interpret aggregate safety data, including signal detection and ad hoc safety assessments.
• Oversee safety aspects of clinical studies and maintenance of core safety information.
• Support safety sections of clinical documents, including protocols, DSURs, final study reports, and other documents.
• Lead development of Risk Management Plans and evaluate their effectiveness.
• Communicate safety issues to stakeholders in a timely fashion.
• Author AOSE and ICSRs comments.
• Maintain knowledge of global regulatory regulations (FDA, EMA) and evolving guidelines.
• Contribute to training and leadership of department staff.
• Perform other duties as assigned.

Qualifications

• MD or equivalent with clinical post-training eligible for US medical board certification.
• Experience in pharmacovigilance, including signal management and ICSRs; pharmaceutical/biotechnology background preferred.
• MPH or pharmacoepidemiology expertise desired.
• Neurology, psychiatry, rare diseases, and CNS-related experience preferred.
• Sr. Director: ~10+ years of relevant drug safety experience with leadership.
• Executive Director: ~15+ years of relevant drug safety experience with leadership.
• Strong knowledge of FDA and EU regulations and ICH guidelines for pharmacovigilance.
• Ability to assess risk-benefit and interpret post-market safety data.
• Ability to adapt to regulatory changes with minimal oversight; collaborative working style.
• Decision-making, prioritization, and deadline management skills.
• Independent initiative and task completion ability.
• Excellent interpersonal, communication, analytical, and organizational skills.
• Proven ability to lead, motivate, and train others.
• Proficient in Microsoft Word, PowerPoint, and Excel.
• Ability to travel domestically and internationally occasionally.

Skills

• Pharmacovigilance leadership
• Signal management and ICSR processing
• Regulatory affairs familiarity (FDA, EMA, ICH)
• Safety monitoring and post-marketing surveillance
• Risk management planning
• Medical writing and safety documentation
• Cross-functional collaboration

Education

• MD or equivalent; clinical board eligibility in the US
• MPH or pharmacoepidemiology expertise desired

Additional Requirements

• Must be able to travel domestically and internationally on occasion.