Acadia advances care for underserved neurological disorders and rare diseases. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. Backed by NEA.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
More about this role
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.
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...
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