Senior Manager, Drug Safety & PV Quality Standards & Training

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 clinical trials, post-marketing surveillance, case processing, and reporting to Health Authorities worldwide.
• Ability to assess evolving regulatory landscape, weigh possible courses of action, provide advice, and make sound decisions.
• Ability to drive standards and change across functional areas and sites.
• Strong attention to detail in establishing priorities, scheduling, and meeting deadlines.
• Ability to work independently, take initiative, and complete tasks to deadlines.
• Excellent interpersonal, communication, analytical, and organizational skills.
• Demonstrated ability to motivate, lead, and train others.
• Willingness and ability to travel as needed.

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Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.