Executive Director Drug Safety and Pharmacovigilance

$271,000 - $339,000/Yr

Acadia Pharmaceuticals - San Diego, CA

Full-time - Senior

San Diego, CA

Professional, Scientific, and Technical Services

About the position

The Executive Director of Drug Safety and Pharmacovigilance at Acadia Pharmaceuticals is responsible for leading the overall strategy and management of pharmacovigilance (PV) activities. This role involves ensuring compliance with regulations, managing safety signals, and communicating with health authorities. The position requires a strong background in drug safety, leadership experience, and the ability to work collaboratively with various stakeholders to enhance patient safety and risk management.

Responsibilities

• Develop strategies to achieve PV Medical Safety goals in collaboration with the Head of Safety.
• Represent PV in communications with health authorities such as the FDA.
• Assess safety signals and trends, proactively managing potential safety issues.
• Formulate response strategies and author responses for health authority requests.
• Determine the need for pharmacoepidemiology and liaise with external experts.
• Ensure compliance of PV Medical Safety activities with regulations and Acadia standards.
• Oversee vendor performance in medical review of ICSRs and aggregate reports.
• Perform medical review of serious adverse events from clinical trials.
• Accountable for medical evaluation of aggregate safety data, including signal detection and ad hoc assessments.
• Provide oversight for safety aspects of clinical studies and maintain core safety information.
• Support safety sections of clinical documents, including protocols and annual reports.
• Lead development and evaluation of Risk Management Plans.
• Communicate safety issues to stakeholders in a timely manner.
• Author analysis of similar events and individual case comments for ICSRs.
• Maintain knowledge of global regulatory authority regulations.

Requirements

• MD degree or equivalent with clinical post-training for US medical board certification eligibility.
• 10+ years of relevant drug safety experience for Senior Director level; 15+ years for Executive Director level in biotechnology/pharmaceutical industry.
• MPH or pharmacoepidemiology expertise desired; experience in neurology, psychiatry, or CNS-related diseases preferred.
• Highly-developed scientific and analytical knowledge base with understanding of good pharmacovigilance practices.
• Proficiency in creating and communicating a clear vision to achieve organizational goals.
• Strength in analysis, critical decision-making, and accountability.
• Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
• Thorough understanding of U.S. pharmacovigilance regulations, GCP, and ICH guidelines.
• Extensive experience in authoring aggregate safety reports and addressing potential safety issues.
• In-depth understanding of the drug development process and experience in vendor partnerships.
• Exceptional written and verbal communication skills.

Nice-to-haves

• Experience in leading training and continuing education for department staff.
• Ability to think strategically and implement change at the executive level.

Benefits

• Competitive base salary and discretionary bonus.
• Equity awards based on performance.
• Medical, dental, and vision insurance.
• 401(k) Plan with a fully vested company match 1:1 up to 5%.
• Employee Stock Purchase Plan with a 2-year purchase price lock-in.
• 15+ vacation days and 14 paid holidays plus one floating holiday.
• 10 days of paid sick time.
• Paid parental leave.
• Tuition assistance.