Senior Medical Safety Scientist

The role

The Senior Medical Safety Scientist serves as the primary scientific safety lead for assigned products. This role drives safety surveillance, signal detection, and benefit-risk evaluations throughout the product lifecycle.

What you will do

• Serve as the scientific safety lead for assigned products
• Conduct routine and ad hoc review of safety data from clinical trials, post-marketing sources, and literature
• Lead signal detection, validation, evaluation, tracking, and aggregate safety analyses
• Author and maintain key safety deliverables including signal assessments and benefit-risk assessments
• Support aggregate safety reports, regulatory submissions, and risk management initiatives
• Provide scientific safety expertise to governance committees and cross-functional teams
• Review safety listings and adverse event summaries to identify emerging safety concerns
• Support audits and regulatory authority inspections
• Maintain knowledge of safety science methodologies and global regulatory requirements

Required qualifications

• 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, and health authority responses
• Advanced knowledge of FDA, EU, and ICH regulations and guidelines
• Expertise in safety signal detection, validation, evaluation, and risk assessment methodologies
• Experience with pharmacovigilance databases and safety systems, including Argus Safety
• 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, 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

About the company

Acadia is committed to turning scientific promise into meaningful innovation for underserved neurological and rare disease communities. Their commercial portfolio includes treatments for Parkinson’s disease psychosis and Rett syndrome.