The posting
About Acadia Pharmaceuticals
Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.
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.
#LI-Hybrid
#LI-CS1
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 [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
California Applicants: Please see Additional Information for California Residents within our Privacy Policy.
Canadian Applicants: Please see Additional Information for Canadian Residents within 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.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
