Executive Director Drug Safety and Pharmacovigilance

Position Summary

In this role this individual will be responsible for overseeing all aspects of product safety across clinical development and post-marketing surveillance. They will support the overall strategy and approaches within Medical Safety and support the PV team on scientific topics. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards and drives the strategy and execution of safety science to protect patient health and optimize product benefit-risk profiles.

Primary Responsibilities

• Develop strategies working with the Head of Safety to achieve PV Medical Safety goals.
• Along with the Head of Safety represent PV in communications with health authorities such as the Food and Drug Administration (FDA).
• Assess safety signals and trends and proactively manage any potential safety issues.
• Formulate response strategies and author responses for health authority requests.
• Determine the need for pharmacoepidemiology including input and liaising with external pharmacoepidemiologists.
• Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and Acadia standards.
• Assist with oversight of the vendor performing medical review of Individual Case Safety Report (ICSR) and aggregate report on behalf of Acadia.
• Perform medical review of serious adverse events from Acadia clinical trials.
• Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation and ad hoc safety assessments.
• Provide oversight for the safety aspects of clinical studies and development and maintenance of Acadias core safety information.
• Provide support for safety sections of clinical documents including the review and approval of the safety portion of protocols annual reports (DSUR) final study reports and other documents as needed.
• Lead development of Risk Management Plans implementation and evaluation of their effectiveness.
• Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
• Author Analysis of Similar Events (AOSE) and individual case comments for ICSRs.
• Maintain knowledge of global regulatory authority regulations including the FDA and European Medicines Agency (EMA).
• Contribute to the training leadership and continuing education of department staff.
• Perform other duties as assigned.

Education/Experience/Skills

• MD degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification.
• Experience in pharmacovigilance preferably in a pharmaceutical or biotechnology company with experience in signal management (e.g. signal detection evaluation ICSRs etc.).
• MPH or pharmacoepidemiology expertise desired.
• Neurology psychiatry Rare and CNS-related disease experience preferred.
• Sr. Director level: Targeting 10 years of relevant drug safety experience in the biotechnology/pharmaceutical industry including safety leadership experience.
• Executive Director level: Targeting 15 years of relevant drug safety experience in the biotechnology/pharmaceutical industry including safety leadership experience.
• Solid knowledge of and experience with FDA and EU regulations and ICH guidelines related to pharmacovigilance including safety monitoring and reporting in clinical trials post-marketing surveillance case processing safety agreement requirements and reporting to Health Authorities worldwide.
• Advanced ability to assess product risk-benefit profiles and interpret post-market safety data.
• Responds appropriately to rapidly changing regulatory environment with minimal oversight.
• Works collaboratively and effectively with colleagues across Acadia to contribute to meeting organizational goals and objectives.
• Ability to assess evolving regulatory landscape weigh possible courses of action provide advice and make sound decisions.
• Strong attention to detail in establishing priorities scheduling and meeting deadlines.
• Ability to work independently take initiative and complete tasks to deadlines.
• Excellent interpersonal communication analytical and organizational skills.
• Demonstrated ability to motivate lead and train others.
• Proficient computer skills including Microsoft Word PowerPoint and Excel.
• Must be able to travel domestically and internationally on occasion.

Physical Requirements

This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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Required Experience:

Director