Senior Medical Safety Scientist

Acadia Pharmaceuticals•San Diego, NJ

1d•Hybrid

About The Position

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. 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.

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

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