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

Responsible for the global, strategic and operational oversight of the quality and compliance of the pharmacovigilance activities in support of Acadia worldwide and in fulfillment of global legislation and regulations. This individual provides direction, leadership and management in shaping pharmacovigilance business policy and process through effective optimization and integration of Operational and Safety Systems functions and capabilities. Works with leadership across Acadia functional areas on the continuous development and improvement of business processes to support pharmacovigilance compliance at a strategic level. This is accomplished through development and execution of global processes, standards, vendor oversight, training programs and compliance monitoring, execution of safety contracts, and maintenance of Acadia's Global Safety System database. Member of the Drug Safety & Pharmacovigilance (DSP) leadership team.

Primary Responsibilities

• Ensures compliant PV system is in place for the collection, collation, evaluation and submission of individual case safety reports and aggregate reports in accordance with international regulatory requirements. Ensures oversight of safety vendor is established and effective.
• Negotiation of vendor contracts to ensure quality, compliance and cost effectiveness.
• Drives implementation of drug safety standards across other areas that input to the PV system such as clinical research, medical affairs, commercial, etc.
• Collaborates to ensure effective system to monitor compliance with reporting requirements including root cause and corrective/preventive actions. Serves as primary liaison with QA during PV inspections and collaborates in preparation of responses to inspection observations. Ensures internal and external audit deficiencies are communicated to functional heads including preparation, prioritizing and monitoring of remediation activities. Provides input to business regarding needs associated with globalization of Acadia products and potential acquisitions.
• Serves as a member of the DSP leadership team to influence the operations and strategy of the DSP department. Alerts Head of Drug Safety and Pharmacovigilance of significant deficiencies in quality and compliance standards and ensures corrective/preventive actions are implemented.
• Oversees development, execution and maintenance of Safety Data Exchange Agreements for all development, licensing, commercialization and distribution partnerships to meet regulatory requirements and protect Acadia assets. Participates, directly or indirectly through delegation, in in-licensing activities by providing input into commercial contractual agreements to meet business and Acadia PV system needs and comply with global regulations.
• Collaborates with the DSP Leadership Team to create a departmental annual strategic action plan. Oversees the implementation of Safety Operations and Safety Systems related initiatives.
• Directs and leads team and ensure oversight of vendor in the management of adverse events (AEs) and other safety information to individual case safety reports (ICSRs) and aggregate reports including Periodic Adverse Drug Experience Reports (PADER) and Periodic Benefit Risk Evaluation Reports (PBRER).
• Provide oversight of Pharmacovigilance System Master File (PSMF) in collaboration with DSP QST and EU Qualified Person for Pharmacovigilance (EU QPPV) for approved products marketed by Acadia under an MAA.
• Oversees the Safety Systems team in the development, maintenance, and management of the pharmacovigilance safety database (ie. Argus). Oversight to ensure all validation documentation needs are met to auditable standards.
• Collaborate with senior leadership to ensure clinical and commercial pharmacovigilance related activities are implemented in compliance with global requirements.
• Evaluate and monitors processes and contracts used by various teams for compliance with corporate and regulatory requirements, collaborating to enhance corporate processes by providing recommendations to optimize compliance.
• Collaborates with DSP Quality, Standards and Training (QST) leadership to develop and implement pharmacovigilance training to support relevant internal and external pharmacovigilance activities.
• Ensures operational and safety system related processes and procedures are created and updated to ensure compliance with global regulatory requirements. Serves as an approver for Safety Operations and Safety Systems related standard operating procedures (SOPs) and Work Instructions (WIs).
• Oversees and assists Safety Systems in the development of Argus reports (i.e., periodic and ad hoc)
• Contributes to the preparation and management of pharmacovigilance audits and inspections by FDA, EMA or other health authorities, including assisting with communication activities and providing strategic advice and regulatory guidance.
• Responsible for the development of responses and oversight of regulatory queries concerning Safety Operations related documentation.
• Collaborates with external stakeholders, including but not limited to Marketing Partners and CROs to ensure the Safety Operations related aspects of processes and agreements are compliant with corporate and regulatory requirements.
• Accountable for effective management of departmental resources, expenses and budget.
• Manage direct reports talent by addressing individual performance needs as well as succession planning.
• Other duties as assigned.

Education/Experience/Skills

M.D., Registered Nurse, Pharm.D, or Bachelor's degree in health sciences or related field. Targeting 12 years in industry with 8 years of Pharmacovigilance leadership and prior oversight of PV compliance, quality and training, external contracts, and database systems. Must have experience and understanding of pharmacovigilance inspections by FDA and other major global Health Authorities. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Experience in quality systems, establishing and tracking performance metrics, compliance monitoring, the development and maintenance of SOPs and training programs, contract negotiation.
• Detailed knowledge of Argus capabilities to ensure efficiency of case processing.
• Experience in implementation and upgrades of PV systems/databases including configuration, validation and testing
• 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, safety agreement requirements, and reporting to Health Authorities worldwide.
• Responds appropriately to rapidly changing regulatory environment with minimal oversight.
• Works collaboratively and effectively with colleagues across Acadia to contribute to meeting organizational goals and objectives.
• Ability to assess evolving regulatory landscape, weigh possible courses of action, provide advice, and make decisions.
• 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.
• Proficient computer skills, including Microsoft Word, PowerPoint and Excel.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

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