Executive Director, Drug Safety and Pharmacovigilance

Role Summary

Executive Director, Drug Safety and Pharmacovigilance — Oversees all aspects of product safety across clinical development and post-marketing surveillance, ensuring PV activities align with regulatory requirements and company standards, and driving safety science strategy and execution.

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 and liaise with external pharmacoepidemiologists.
• Ensure PV Medical Safety activities comply with regulations and Acadia standards.
• Oversee vendors performing medical review of ICSRs and aggregate reports.
• Perform medical review of serious adverse events from clinical trials.
• Accountable for medical evaluation/interpretation of aggregate safety data, including signal detection and ad hoc safety assessments.
• Provide safety oversight for clinical studies and development/maintenance of core safety information.
• Support safety sections of clinical documents, including safety portions of protocols, DSURs, final study reports, and other documents.
• Lead development of Risk Management Plans and evaluate their effectiveness.
• Ensure safety issues are communicated to stakeholders in a timely fashion.
• Author Analysis of Similar Events (AOSE) and ICSRs comments.
• Maintain knowledge of global regulatory regulations (FDA, EMA) and evolving requirements.
• Contribute to training, leadership, and continuing education 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, preferably in pharma/biotech with signal management experience.
• MPH or pharmacoepidemiology expertise desired.
• Neurology, psychiatry, rare and CNS disease experience preferred.
• Sr. Director: 10+ years of drug safety in biotech/pharma with safety leadership.
• Executive Director: 15+ years of drug safety with safety leadership.
• Strong knowledge of FDA/EU regulations and ICH guidelines related to pharmacovigilance.
• Ability to assess risk-benefit and interpret post-market safety data.
• Ability to adapt to regulatory changes with minimal oversight.
• Collaborative, detail-oriented, able to work independently and meet deadlines.
• Excellent interpersonal, communication, analytical, and organizational skills.
• Proven ability to motivate, lead, and train others.
• Proficient in Word, PowerPoint, Excel.
• Willingness to travel domestically and internationally.

Education

• MD or equivalent (US board eligibility required) and relevant pharmacovigilance experience.
• MPH/pharmacoepidemiology expertise preferred.

Additional Requirements

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