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
Bachelor’s degree in healthcare, life sciences or a related field. Targeting 10 years of progressively responsible experience in pharmacovigilance operations and or pharmacovigilance quality functions, with working knowledge of global pharmacovigilance requirements, preferably in a pharmaceutical or biotech environment. An equivalent combination of relevant education and experience may be considered. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Experience representing PV in quality audits and inspections, including CAPA implementation
- Proficiency in creating and maintaining quality systems, establishing and tracking performance metrics, compliance monitoring, developing and maintaining SOPs and training programs, and PV systems/databases
- Ability to independently translate regulatory requirements into practical processes and drive cross-functional implementation
- Demonstrated experience conducting regulatory gap assessments and developing or revising SOPs and work instructions
- Effective written and verbal communication skills, including the ability to develop clear and concise documentation and training materials
- Proficient in pharmacovigilance databases, quality systems, and training platforms
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.
This is a hybrid role based in San Francisco, CA, San Diego, CA, or Princeton, NJ with an expectation to work onsite three days per week.
Position Summary
The Director, Global PV Management is responsible for assessing regional and international pharmacovigilance regulatory requirements and translating them into effective drug safety & pharmacovigilance (DSP) procedures and operational processes. In partnership with DSP team members and other cross-functional key stakeholders, the role monitors regulatory changes in existing...
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