Director Drug Safety & Pharmacovigilance Medical Safety

Acadia Pharmaceuticals Inc.•Princeton, NJ

5h•Hybrid

About The Position

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. The Director of Drug Safety & Pharmacovigilance is a medical safety expert within the Drug Safety & Pharmacovigilance (PV) function, reporting to the Executive Director of Medical Safety. This role serves as the primary medical safety resource for assigned products across the Acadia portfolio, providing hands-on medical evaluation of safety data, signal detection and assessment, and clinical oversight of pharmacovigilance activities throughout the product lifecycle. The Director contributes product-level medical input to cross-functional safety governance, collaborates with the Executive Director of Medical Safety on complex or escalated safety issues, and supports regulatory submissions and health authority interactions for assigned products.

Requirements

MD (Doctor of Medicine) or equivalent medical degree from an accredited institution, with relevant postgraduate clinical training and experience
6 to 7 years of relevant drug safety experience, including expertise in safety signal management (signal detection, evaluation, aggregate data review, ICSRs), preferably in a pharmaceutical or biotech environment
Advanced knowledge of FDA, EU, and ICH regulations and guidelines related to pharmacovigilance, including clinical trial safety monitoring, post-marketing surveillance, ICSR processing, aggregate reporting, and health authority reporting requirements
Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data
Demonstrated expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases
Ability to author and critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses)
Strong analytical and critical decision-making skills; ability to manage competing priorities and meet deadlines with minimal oversight
Experience with pharmacovigilance safety databases (Argus) and signal detection tools
Excellent interpersonal, written, and oral communication skills; ability to effectively communicate complex safety findings to internal and external stakeholders
Proficiency in MS Office Suite (Word, PowerPoint, Excel)
Ability to manage multiple priorities and work cross-functionally in a fast-paced environment
Must be willing and able to travel both domestically and internationally

Nice To Haves

Candidates who are eligible for U.S. medical board certification are preferred
MPH or pharmacoepidemiology training is a plus
Neurology, psychiatry, rare disease, or CNS-related therapeutic area experience strongly preferred
Familiarity with pharmacoepidemiology concepts and study design

Responsibilities

Serves as the primary medical safety resource for assigned Acadia products, providing product-level clinical safety and pharmacovigilance expertise across all stages of development and post-marketing surveillance
Performs medical evaluation and interpretation of aggregate safety data for assigned products, including signal detection and evaluation, ad hoc safety assessments, and benefit-risk analyses; escalates complex or novel safety issues appropriately
Assesses safety signals and trends for assigned products and proactively manages potential safety issues in collaboration with cross-functional stakeholders
Contributes product-level medical input to the Medical Safety team and other cross-functional safety governance bodies
Performs medical review of all serious adverse events from Acadia clinical trials for assigned products
Performs retrospective medical review of adverse events for post-marketed products
Authors Analysis of Similar Events (AOSE) and individual case narratives and comments for ICSRs for assigned products
Provides oversight for the safety aspects of clinical studies for assigned products, including development and maintenance of product-specific core safety information
Reviews and approves safety sections of clinical documents for assigned products, including protocols, DSURs, final study reports, and other documents as required
Formulates response strategies and authors health authority responses for safety-related queries pertaining to assigned products, in collaboration with the Head of Medical Safety
Provides medical input into Periodic Benefit Risk Evaluation Reports (PBRERs) for assigned products, including clinical interpretation of safety data
Provides medical and scientific input into Risk Management Plans (RMPs/dRMPs) and REMS programs for assigned products
Ensures all PV Medical Safety activities for assigned products are performed in compliance with applicable regulations and Acadia standards
Maintains current knowledge of global regulatory authority regulations and guidance
Other responsibilities as assigned

Benefits

Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
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
13 -15 paid holidays, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave benefit
Tuition assistance