Senior Medical Safety Scientist
Acadia Pharmaceuticals Inc.
Summary
The 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.
Job description
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
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
Requirements
- 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
Benefits
- Competitive base salary
- Discretionary bonus
- Equity awards
- Medical, dental & vision insurance
- Employer-paid life insurance
- Disability insurance
- Business travel coverage
- EAP coverage
- 401(k) matching
- Employee Stock Purchase Plan
- 15+ vacation days
- 13-15 paid holidays
- Paid sick time
- Paid parental leave
- Tuition assistance
Company overview
Acadia Pharmaceuticals Inc. is a biopharmaceutical company headquartered in San Diego, California, founded in 1993. The company specializes in developing and commercializing innovative therapies for underserved neurological disorders and rare diseases. Acadia has pioneered the first and only FDA-approved treatments for Parkinson's disease psychosis (NUPLAZID®) and Rett syndrome (DAYBUE®). With a workforce of 501-1,000 employees, the company maintains a robust pipeline focused on addressing unmet medical needs in Alzheimer's disease psychosis, Lewy body dementia psychosis, Prader-Willi syndrome, and other central nervous system disorders. Acadia operates with a mission to transform scientific promise into meaningful innovations that improve patient lives, particularly in neurological and rare disease communities where treatment options are limited. The company is publicly traded on NASDAQ under the symbol ACAD and has established itself as a leader in neuroscience therapeutics through its commitment to research, development, and patient-centered care.