Senior Medical Safety Scientist
Acadia Pharmaceuticals Inc. · Princeton, New Jersey, United States; San Diego, California, United States · $145k–$181.7k
Posted by Acadia Pharmaceuticals Inc. on their careers site · View the original posting
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About Acadia Pharmaceuticals
Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.
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 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. 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, inspe
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m, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923 .
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
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Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.