Please note that this position is based in either San Diego, CA, or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.Position SummaryThe Senior Medical Safety Scientist is a scientific safety expert within Drug Safety & Pharmacovigilance (PV), reporting to the Executive Director, Drug Safety & Pharmacovigilance, Medical Safety. This role serves as the primary scientific safety lead for assigned products across the Acadia portfolio, driving safety surveillance, signal detection and evaluation, aggregate safety assessments, and benefit-risk evaluations throughout the product lifecycle. The Senior Medical Safety Scientist collaborates closely with Safety Physicians and cross-functional stakeholders to proactively identify, evaluate, communicate, and manage safety risks while supporting regulatory submissions and safety governance activities.
Primary Responsibilities- Serve as the scientific safety lead for assigned products, providing pharmacovigilance expertise across clinical development and post-marketing activities
- Conduct routine and ad hoc review of safety data from clinical trials, post-marketing sources, literature, business partners, and other relevant sources to support ongoing safety surveillance
- Lead signal detection, validation, evaluation, tracking, and aggregate safety analyses, including review of case series, adverse event trends, data mining outputs, and benefit-risk assessments
- Author and maintain key safety deliverables including signal assessments, safety evaluations, benefit-risk assessments, safety narratives, AOSEs, Safety Surveillance Plans (SSPs), and signal management documentation
- Support aggregate safety reports, regulatory submissions, health authority responses, core safety information, Risk Management Plans (RMPs), REMS activities, and other product risk management initiatives
- Provide scientific safety expertise to governance committees and cross-functional teams, including Clinical Development, Regulatory Affairs, Biostatistics, Medical Writing, Epidemiology, Medical Affairs, and Quality
- Review safety listings, line listings, adverse event summaries, and retrospective safety data analyses to identify and evaluate emerging safety concerns and risks
- Support audits, inspections, and regulatory authority inspections by ensuring safety documentation is accurate, complete, and inspection ready while maintaining compliance with global pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP)
- Maintain current knowledge of safety science methodologies, signal management practices, and evolving global regulatory requirements
- Other duties as assigned
Education/Experience/Skills- PharmD, PhD, MS, MSN, MPH, RN, NP, PA, or equivalent degree from an accredited institution
- 7+ years of experience in drug safety, pharmacovigilance, clinical safety, or risk management within the pharmaceutical or biotechnology industry
- Experience in safety surveillance, signal detection and management, aggregate safety data review, benefit-risk assessment, and product safety evaluation
- Experience authoring regulatory safety documents including signal assessments, DSURs, PBRERs, safety sections of clinical documents, aggregate reports, and health authority responses
- Advanced knowledge of FDA, EU, and ICH regulations and guidelines related to pharmacovigilance, clinical trial safety monitoring, signal management, aggregate reporting, and post-marketing surveillance
- Expertise in safety signal detection, validation, evaluation, and risk assessment methodologies
- Experience with pharmacovigilance databases and safety systems, including Argus Safety, as well as signal detection tools
- Strong knowledge of MedDRA coding conventions, safety data review methodologies, and adverse event analysis
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Ability to travel domestically and internationally as required
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In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
Salary Range
$145,000-$181,700 USD
What we offer US-based Employees:- 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
