Senior Manager, Drug Safety & PV Quality Standards & Training

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 Acadia.com and follow us on LinkedIn and X.

 

Please note that this position can be 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.

In support of Acadia and fulfillment of global legislation and regulations, the Senior Manager will be responsible for the global oversight for quality and compliance of the Pharmacovigilance (PV) and risk management activities. This is accomplished through setting and articulating the vision for the PV system including but not limited to development and execution of global processes, standards, training programs and compliance monitoring.

This role requires in-depth knowledge of the functional area and a strong understanding of organizational objectives to address moderate to complex issues. The individual will develop and apply methods, techniques, and evaluation criteria across projects and programs. Decisions made in this position carry significant weight and can directly impact both the success of the function and the company’s short-term performance.

Primary Responsibilities

• Supports all compliant PV system-related activities by ensuring appropriate processes are in place for the collection, collation, evaluation, and submission of individual case safety reports and aggregate reports in accordance with international regulatory requirements.
• Assists with implementing drug safety standards across other areas that input to the PV system, such as clinical research, medical affairs, commercial, etc.
• Contributes to preparing and presenting Key Performance Indicator (KPI) reports.
• Supports Drug Safety and PV (DSP) Training administration and management. Liaises with Acadia stakeholders to ensure all vendors are properly trained and that training is documented.
• Maintains all required SOP training matrices for all DSP roles. 
• Supports PV inspections and audits; collaborates cross-functionally in preparation of responses to findings.
• Leads monitoring and management of DSP quality events/deviations investigations.
• Evaluate adequacy and completeness of CAPAs and Effectiveness Checks (ECs) originated from audits, and/or quality events/deviations.
• Supports Quality Management Reviews for all DSP deliverables.
• Supports DSP procedural development and maintenance; collaborates with Subject Matter Experts (SMEs); liaises with other departments on cross-functional procedures that involve DSP.
• Supports Regulatory Intelligence for DSP
• Contributes to documents describing the Acadia PV system as required by regulations (e.g., EU PV Masterfile).
• Assist in preparing and executing the DSP Business Continuity Plan in collaboration with other stakeholders (e.g., IT, Regulatory).
• Other duties as assigned. 

Education and Experience

• Bachelor's degree in Life Science or related field.  Targeting 7 years of progressively responsible experience within the pharmaceutical or biotech industry, including 3 years in Pharmacovigilance with prior oversight of PV compliance, quality and training. 
• Must have experience with industry interpretation of regulatory expectations and with pharmacovigilance inspections by major global Health Authorities.  An equivalent combination of relevant education and experience may be considered.
• Experience in quality systems, establishing and tracking performance metrics, compliance monitoring, developing and maintaining SOPs and training programs, and PV systems/databases. Experience with Veeva and ARGUS is preferred.
• Solid knowledge of and experience with FDA and EU regulations and ICH guidelines related to pharmacovigilance, including safety monitoring and reporting in