Director, Global PV Management

Acadia Pharmaceuticals Inc.•San Diego, CA

4d•$194,600 - $243,300•Hybrid

About The Position

The Director, Global PV Management assesses regional and international pharmacovigilance (PV) regulatory requirements and translates them into effective drug safety and pharmacovigilance procedures and operational processes. In partnership with Drug Safety & Pharmacovigilance team members and cross-functional stakeholders, this role monitors regulatory changes in existing markets, evaluates requirements for entering new countries, and develops and implements processes to support ongoing compliance and operational readiness. The position works with the Qualified Person for Pharmacovigilance, local country PV responsible persons, internal teams, and external service providers. It leads regulatory gap assessments and procedure development, tracks implementation, evaluates adherence, escalates compliance risks, and supports inspection readiness. This is a hybrid role based in San Francisco, San Diego, or Princeton, 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, or an equivalent combination of relevant education and experience.
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 PV 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, performance metrics, compliance monitoring, SOPs, training programs, and PV systems or databases.
Ability to translate regulatory requirements into practical processes and drive cross-functional implementation independently.
Experience conducting regulatory gap assessments and developing or revising SOPs and work instructions.
Effective written and verbal communication skills, including clear documentation and training materials.
Proficiency with pharmacovigilance databases, quality systems, and training platforms.
Demonstrated ability to drive operational excellence, inspection readiness, and process improvement.
Ability to motivate and train others and drive standards and change across functional areas and sites.
Strong attention to detail in setting priorities, scheduling, and meeting deadlines.
Strong analytical thinking, strategic writing, project management, and communication across diverse stakeholders.
Ability to manage multiple priorities in a fast-paced, cross-functional environment.
Must be able and willing to travel occasionally.
Ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
Ability to perform the stated physical activities, including occasionally lifting or moving up to 20 pounds.

Responsibilities

Review and interpret regional and international pharmacovigilance requirements and assess their impact on company procedures, processes, and outsourced activities.
Monitor changes to PV requirements in countries where the company operates and coordinate timely assessment and implementation.
Assess PV 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 practices.
Lead development and revision of PV procedures with cross-functional stakeholders and service providers.
Collaborate with the QPPV and local country PV responsible persons to assess country-specific requirements and incorporate them into company procedures and processes.
Translate regulatory requirements into operational steps, ownership, and timelines.
Coordinate procedure review and implementation and verify that changes are reflected in operational practice.
Maintain centralized records of applicable requirements, gaps, action owners, implementation status, and supporting documentation.
Evaluate SOPs and processes for compliance gaps, inconsistencies, and improvement opportunities.
Partner with the Head of Pharmacovigilance Operations and PV Quality Services & Training to assess adherence through process checks and coordinate follow-up, training, or improvements.
Escalate compliance risks and overdue actions to PV leadership and recommend solutions.
Support inspection readiness and responses to findings through regulatory assessments, procedure updates, and supporting evidence.
Represent PV in quality audits and inspections and support CAPA implementation.
Collaborate with Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, and Legal to align PV quality strategies.
Engage external vendors and partners to support compliance with PV-related contractual agreements.
Monitor emerging regulations and industry trends and enhance PV processes and best practices.
Contribute to best practices, training materials, and procedural guidance; promote accountability, compliance, and continuous improvement.
Manage multiple priorities and work cross-functionally in a fast-paced environment.
Travel occasionally as required.
Perform other responsibilities as assigned.

Benefits

Competitive base salary and eligibility for discretionary bonus and equity awards
Medical insurance
Dental insurance
Vision insurance
Employer-paid life insurance
Employer-paid disability coverage
Employer-paid business travel coverage
Employee Assistance Program coverage
401(k) plan with fully vested company match of 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13–15 paid holidays, including office closure between December 24 and January 1
10 days of paid sick time
Paid parental leave
Tuition assistance
New hire and ongoing equity packages