Senior Director of Pharmacovigilance and Drug Safety
1 week ago
Acadia Pharmaceuticals is a leading biopharmaceutical company dedicated to advancing breakthroughs in neuroscience to elevate life. With a rich history of innovation, we have been at the forefront of healthcare for over 30 years, bringing vital solutions to people who need them most. Our commitment to excellence has led to the development and commercialization of the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis and the first and only FDA-approved drug for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis, and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit our website and follow us on LinkedIn and X.
Job SummaryWe are seeking a highly skilled and experienced Senior Director of Pharmacovigilance and Drug Safety to join our team. As a key member of our Medical Safety department, you will be responsible for supporting the overall strategy and approaches within Medical Safety and working closely with the PV management on scientific topics. You will also interact with Acadia executives/leaders on issues related to benefit/risk and be responsible for content and quality of Acadia risk communications.
Key Responsibilities- Develop strategies to achieve PV Medical Safety goals, working closely with the Head of Safety.
- Represent PV in communications with health authorities such as the FDA, alongside the Head of Safety.
- 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 liaison 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 ICSRs 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 the company 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, IB, 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 FDA and EMA.
- Contribute to the training, leadership, and continuing education of department staff.
- Other duties as assigned.
- MD degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification.
- Targeting 12 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including safety leadership experience.
- MPH or pharmacoepidemiology expertise desired.
- Neurology, psychiatry, or CNS-related disease experience preferred.
- Competitive base, bonus, new hire, and ongoing equity packages.
- 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.
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st.
- 10 days of paid sick time.
- Paid parental leave.
- Tuition assistance.
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