Associate Director Drug Safety & PV Operations

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

 

Position Summary

The Associate Director, Drug Safety and Pharmacovigilance Operations plays a critical role in ensuring the safety and compliance of Acadia's clinical and marketed products by driving operational excellence across global pharmacovigilance (PV) activities. Acting as a key representative of Safety Operations, this role collaborates closely with the Safety Physician and cross-functional stakeholders to monitor product safety, manage vendor partnerships, and ensure timely regulatory submissions. The individual contributes to identifying safety signals and risk management strategies, oversees the execution of safety reporting processes, and champions continuous improvement across PV systems and procedures. This position requires a deep understanding of global PV regulations, a proactive approach to compliance, and the ability to lead through collaboration and influence.

**Please note that this position is based in San Diego, CA. or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.**
 

Primary Responsibilities

• Participates in setting direction of PV operational activities to ensure a cost-effective and scalable PV system in place.
• Provides oversight of safety information processing, reconciliation and reporting by outsourced vendors, including the review of Individual Case Safety Reports (ICSR), and review of case processing metrics.
• Management of aggregate reports, including Development Safety Update Report (DSUR).
• Participates in the development and management of the Pharmacovigilance System Master File (PSMF).
• Liaises with DSP Quality Standards and Training (QST) in the review of Key performance Indicators (KPIs) including case quality, reporting and workflow metrics to assess vendor performance and takes appropriate action.
• Liaises cross functionally to ensure needed PV requirements are in contracts of other vendors in receipt of safety information. (e.g. Commercial) and ensures appropriate procedures and processes are in place for the receipt and reconciliation of such information.
• Monitors global regulatory intelligence to ensure DSP requirements with safety reporting
• Liaises with global teams on execution of deliverables, such as study deliverables, aggregate reporting, and post marketing activities.
• Acts as safety lead for various ACADIA studies to ensure all PV activities are complete and compliant.
• In collaboration with Regulatory Affairs and/or Contract Service Provider, ensures timely submission of expedited and aggregate safety reports to Regulatory Authorities.
• Develops, reviews and updates drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e. SAE data collection form, PADER template etc.).
• Participates in the management of safety data exchange agreements with business partners if required.
• May participate in strategic planning, workflow development, audits and regulatory inspections.
• Updates key documents including Safety Management Plans, Vendor Oversight Plans, Safety Reporting Forms, narratives and AOSE templates, and other safety related documentation as needed
• Ensures training of appropriate cross-functional personnel and external groups in drug safety principles and practices.
• Identifies and develops process improvement strategies and communicate project status updates.
• Ensures compliance with global regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements.
• Other duties as assigned.

Education/Experience/Skills

Bachelor’s degree in life sciences or related field.  Targeting 8 years of progressively experience in the pharmaceutical or biotech industry with