Director, Global PV Management

Acadia Pharmaceuticals•San Diego, NJ

2d•Hybrid

About The Position

The Director, Global PV Management assesses regional and international pharmacovigilance regulatory requirements and translates them into effective drug safety and pharmacovigilance (DSP) procedures and operational processes. In partnership with DSP colleagues and cross-functional stakeholders, this role monitors regulatory changes in existing markets, assesses pharmacovigilance requirements for entry into new countries, and drives processes that support ongoing compliance and operational readiness. The role leads regulatory gap assessments and the development and revision of pharmacovigilance procedures, coordinates implementation, monitors adherence, maintains records of requirements and actions, and supports inspection readiness and responses to findings. It collaborates with the Qualified Person for Pharmacovigilance, local country pharmacovigilance responsible persons, internal teams, and external service providers. This is a hybrid role based in San Francisco, California; San Diego, California; or Princeton, New Jersey, with an expectation to work onsite three days per week. Occasional travel is required.

Requirements

Bachelor’s degree in healthcare, life sciences, or a related field; an equivalent combination of relevant education and experience may be considered.
Targeting 10 years of progressively responsible experience in pharmacovigilance operations and/or pharmacovigilance quality functions.
Working knowledge of global pharmacovigilance requirements, preferably in a pharmaceutical or biotech environment.
Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, MHRA, PMDA, and Health Canada requirements, and industry best practices such as ICH E2E and GVP modules.
Knowledge of safety monitoring and reporting in clinical trials, post-marketing surveillance, case processing, safety agreement requirements, and reporting to health authorities worldwide.
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 and 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 developing clear and concise documentation and training materials.
Proficiency in pharmacovigilance databases, quality systems, and training platforms.
Demonstrated ability to drive operational excellence, inspection readiness, and process improvements.
Ability to motivate and train others and drive standards and change across functional areas and sites.
Strong attention to detail and ability to establish priorities, schedule work, and meet deadlines.
Strong analytical thinking, strategic writing, project management, and clear communication across diverse stakeholders.
Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.
Ability and willingness to travel on occasion.

Responsibilities

Review and interpret international and regional pharmacovigilance regulatory requirements and assess their impact on company procedures, processes, and outsourced activities.
Monitor pharmacovigilance requirements in countries where the company operates and coordinate timely assessment and implementation of changes.
Assess pharmacovigilance requirements for new countries and develop operational readiness plans, including procedures, responsibilities, and implementation timelines.
Conduct and document gap assessments comparing regulatory requirements with existing SOPs, work instructions, and operational practices.
Lead the development and revision of pharmacovigilance procedures in collaboration with cross-functional stakeholders and service providers.
Collaborate with the Qualified Person for Pharmacovigilance and local country pharmacovigilance responsible persons to assess requirements and incorporate them into company procedures and processes.
Translate regulatory requirements into clear operational steps, defined ownership, and actionable timelines.
Coordinate procedure review and implementation and verify that required changes are incorporated into operational practice.
Maintain centralized records of applicable requirements, identified gaps, action owners, implementation status, and supporting documentation.
Evaluate SOPs and processes to identify compliance gaps, inconsistencies, and opportunities for improvement.
Partner with the Head of Pharmacovigilance Operations and PV Quality Services & Training to assess adherence through targeted, routine process checks.
Identify gaps and coordinate follow-up actions, including procedure clarification, training, or process improvements.
Escalate compliance risks and overdue actions to PV leadership and recommend practical solutions.
Support inspection readiness and responses to findings through regulatory assessments, procedure updates, and supporting evidence.
Represent pharmacovigilance in quality audits and inspections, including CAPA implementation.
Develop and maintain quality systems, performance metrics, compliance monitoring, SOPs, and training programs.
Collaborate with internal teams, including Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, and Legal, to align PV quality strategies.
Engage with external vendors and partners to ensure compliance with PV-related contractual agreements.
Monitor emerging regulations and industry trends and enhance PV processes to maintain compliance.
Identify process gaps and implement best practices and scalable, efficient workflows.
Contribute to best practices, training materials, and procedural guidance, and promote accountability, compliance, and continuous improvement.
Perform other responsibilities as assigned.