Director Drug Safety & Pharmacovigilance Medical Safety
Acadia Pharmaceuticals
June 27, 2026
Remote friendly (Princeton, NJ)
United States
Medical Affairs
Position Summary
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. Serves as the primary medical safety resource for assigned products, providing hands-on medical evaluation of safety data, signal detection and assessment, and clinical oversight of pharmacovigilance activities throughout the product lifecycle. Contributes product-level medical input to cross-functional safety governance, supports regulatory submissions and health authority interactions.
Primary Responsibilities
- Primary medical safety resource for assigned products across development and post-marketing surveillance
- Medical evaluation/interpretation of aggregate safety data (signal detection/evaluation, ad hoc safety assessments, benefit-risk analyses); escalates complex/novel issues
- Assess safety signals/trends and proactively manage potential safety issues with cross-functional stakeholders
- Medical review of all serious adverse events from clinical trials
- Retrospective medical review of adverse events for post-marketed products
- Author AOSE and individual case narratives/comments for ICSRs
- Oversight of clinical study safety aspects; maintain product-specific core safety information
- Review/approve safety sections of clinical documents (protocols, DSURs, final study reports, etc.)
- Formulate strategies and author health authority responses for safety-related queries (with Head of Medical Safety)
- Medical input into PBRERs and into RMPs/dRMPs and REMS
- Ensure PV Medical Safety activities comply with regulations and company standards
- Maintain knowledge of global regulatory guidance
Education/Experience/Skills
- MD or equivalent medical degree; postgraduate clinical training; U.S. board certification eligibility preferred. MPH or pharmacoepidemiology training is a plus.
- 6–7 years relevant drug safety experience, including safety signal management (signal detection/evaluation, aggregate review, ICSRs), preferably in pharma/biotech
- Strongly preferred: neurology, psychiatry, rare disease, or CNS therapeutic area experience
- Advanced knowledge of FDA/EU/ICH pharmacovigilance requirements (clinical safety monitoring, post-marketing, ICSR processing, aggregate reporting, health authority reporting)
- Ability to assess benefit-risk and interpret clinical/post-market safety data
- Expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases
- Ability to author/critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses)
- Strong analytical/decision-making; manages competing priorities and deadlines with minimal oversight
- Experience with pharmacovigilance safety databases (Argus) and signal detection tools
- Familiarity with pharmacoepidemiology concepts/study design
- Excellent communication skills; proficiency in MS Office
- Travel domestically/internationally
Benefits
- Competitive base salary; eligible for discretionary bonus and equity awards
Salary Range
- $221,000—$275,700 USD
What we offer US-based Employees
- Medical, dental, vision; employer-paid life/disability/business travel/EAP; 401(k) match 1:1 up to 5%; ESPP; 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance
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. Serves as the primary medical safety resource for assigned products, providing hands-on medical evaluation of safety data, signal detection and assessment, and clinical oversight of pharmacovigilance activities throughout the product lifecycle. Contributes product-level medical input to cross-functional safety governance, supports regulatory submissions and health authority interactions.
Primary Responsibilities
- Primary medical safety resource for assigned products across development and post-marketing surveillance
- Medical evaluation/interpretation of aggregate safety data (signal detection/evaluation, ad hoc safety assessments, benefit-risk analyses); escalates complex/novel issues
- Assess safety signals/trends and proactively manage potential safety issues with cross-functional stakeholders
- Medical review of all serious adverse events from clinical trials
- Retrospective medical review of adverse events for post-marketed products
- Author AOSE and individual case narratives/comments for ICSRs
- Oversight of clinical study safety aspects; maintain product-specific core safety information
- Review/approve safety sections of clinical documents (protocols, DSURs, final study reports, etc.)
- Formulate strategies and author health authority responses for safety-related queries (with Head of Medical Safety)
- Medical input into PBRERs and into RMPs/dRMPs and REMS
- Ensure PV Medical Safety activities comply with regulations and company standards
- Maintain knowledge of global regulatory guidance
Education/Experience/Skills
- MD or equivalent medical degree; postgraduate clinical training; U.S. board certification eligibility preferred. MPH or pharmacoepidemiology training is a plus.
- 6–7 years relevant drug safety experience, including safety signal management (signal detection/evaluation, aggregate review, ICSRs), preferably in pharma/biotech
- Strongly preferred: neurology, psychiatry, rare disease, or CNS therapeutic area experience
- Advanced knowledge of FDA/EU/ICH pharmacovigilance requirements (clinical safety monitoring, post-marketing, ICSR processing, aggregate reporting, health authority reporting)
- Ability to assess benefit-risk and interpret clinical/post-market safety data
- Expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases
- Ability to author/critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses)
- Strong analytical/decision-making; manages competing priorities and deadlines with minimal oversight
- Experience with pharmacovigilance safety databases (Argus) and signal detection tools
- Familiarity with pharmacoepidemiology concepts/study design
- Excellent communication skills; proficiency in MS Office
- Travel domestically/internationally
Benefits
- Competitive base salary; eligible for discretionary bonus and equity awards
Salary Range
- $221,000—$275,700 USD
What we offer US-based Employees
- Medical, dental, vision; employer-paid life/disability/business travel/EAP; 401(k) match 1:1 up to 5%; ESPP; 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance