Director, Global PV Management

Acadia Pharmaceuticals; Princeton (NJ); Hybrid; USD 195,000 - 243,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid holidays

Job summary

Acadia Pharmaceuticals Inc. is seeking a Director, Global PV Management for a hybrid role based in San Francisco, CA, San Diego, CA, or Princeton, NJ with onsite three days per week.

You will assess regulatory PV requirements and drive DSP procedures and operational processes across regions. You will lead PV SOP development, collaborate with QPPV and country leads, and ensure timely implementation of regulatory changes, inspections readiness, and continuous process improvements across global

Qualifications

• Strong knowledge of global pharmacovigilance regulations (FDA/EMA/MHRA/MHRA) and ICH/GVP practices.
• Experience representing PV in audits and inspections, including CAPA deployment.
• Ability to develop and maintain SOPs, training programs, and PV systems/databases.
• Proven track record translating regulatory requirements into actionable processes.

Responsibilities

• Review regional and international PV regulatory requirements and impact on procedures.
• Monitor PV regulatory changes and implement necessary updates.
• Assess PV requirements for new markets and develop readiness plans.
• Lead development and revision of PV procedures with cross-functional teams.
• Collaborate with QPPV and country PV leads to ensure compliance.
• Translate requirements into operational steps, ownership, and timelines.
• Coordinate procedure reviews and ensure changes are reflected in practice.
• Maintain a centralized record of requirements, gaps, owners, and status.
• Evaluate SOPs to identify compliance gaps and drive improvements.
• Support inspections readiness and responses to findings.

Skills

Regulatory PV knowledge

Cross-functional collaboration

Regulatory compliance

Project management

FDA/EMA/MHRA knowledge

Education

Bachelor's degree in life sciences

Job description

This is a hybrid role based in San Francisco, CA, San Diego, CA, or Princeton, NJ with an expectation to work onsite three days per week.

Position Summary

The Director, Global PV Management is responsible for assessing regional and international pharmacovigilance regulatory requirements and translating them into effective drug safety & pharmacovigilance (DSP) procedures and operational processes. In partnership with DSP team members and other cross-functional key stakeholders, the role monitors regulatory changes in existing markets, assesses PV requirements for entry into new countries, and drives the development and implementation of processes that enable ongoing compliance and operational readiness.

Primary Responsibilities:

• Review and interpret applicable international and regional pharmacovigilance regulatory requirements and assess their impact on company procedures, processes, and outsourced activities.

• Continuously monitor changes to pharmacovigilance requirements in countries where the company operates and coordinate timely assessment and implementation of necessary changes.

• Assess pharmacovigilance requirements for new countries and develop operational readiness plans, including required 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, working with Regulatory, Quality, Medical Safety, Risk Management, QST, other cross-functional stakeholders, and service providers, as applicable to ensure requirements are appropriately addressed.

• Collaborate with the Qualified Person for Pharmacovigilance (QPPV) and local country pharmacovigilance responsible persons to assess country-specific requirements, confirm their operational impact, and ensure appropriate incorporation 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 have been incorporated into operational practice.

• Maintain a centralized record of applicable requirements, identified gaps, action owners, implementation status, and supporting documentation.

• Regularly 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 periodically assess adherence to established procedures through targeted, routine process checks. Identify gaps and coordinate appropriate follow-up, 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.

• Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in healthcare, life sciences or a related field. Targeting 10 years of progressively responsible experience in pharmacovigilance operations and or pharmacovigilance quality functions, with working knowledge of global pharmacovigilance requirements, preferably in a pharmaceutical or biotech environment. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Strong knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, MHRA, PMDA, Heath Canada) and industry best practices (ICH E2E, GVP modules), including 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/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 the ability to develop clear and concise documentation and training materials.

• Proficient 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; drive standards and change across functional areas and sites.

• Strong attention to detail in establishing priorities, scheduling and meeting deadlines.

• Demonstrated strong analytical thinking, strategic writing, project management, and clear, effective communication across diverse stakeholders.

• Collaborate with internal teams, including Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, and Legal, to ensure alignment of PV quality strategies.

• Engage with external vendors and partners to ensure compliance with PV-related contractual agreements.

• Monitor and assess emerging regulations and industry trends to proactively enhance PV processes and ensure compliance.

• Foster continuous improvement by identifying process gaps related to PV and implementing best practices and ensuring scalable and efficient workflows.

• Contribute to the development of best practices, training materials, and procedural guidance.

• Promote a culture of accountability, compliance, and continuous improvement.

• Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.
• Must be able and willing to travel on occasion.

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.

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range

$194,600—$243,300 USD

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel and EAP coverage
• 401(k) Plan with a fully vested company match 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 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [e-mail] or 858-261-2923.

California Applicants: Please see Additional Information for California Residents within our Privacy Policy.

Canadian Applicants: Please see Additional Information for Canadian Residents with in our Privacy Policy.

Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.