Director, Global PV Management

The posting, as Acadia Pharmaceuticals Inc. wrote it

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, implementati

[…]
m, 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 talentacquisition@acadia-pharm.com 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 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.

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.