Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

Tailor your resume to this Director, Global PV Management role.

Rezi rewrites your resume against Acadia Pharmaceuticals Inc.'s job description. Free.

Resume score gauge reading 58 out of 100

Don't guess if your resume is good enough.

See how it scores against the Director, Global PV Management posting at Acadia Pharmaceuticals Inc. — free, in seconds.

About the Role

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. This role monitors regulatory changes, assesses PV requirements for new countries, and drives the development and implementation of processes for ongoing compliance and operational readiness.

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.

Requirements

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.
Working knowledge of global pharmacovigilance requirements, preferably in a pharmaceutical or biotech environment.
An equivalent combination of relevant education and experience may be considered.
Experience representing PV in quality audits and inspections, including CAPA implementation.
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.
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.

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.
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.
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.

Location

San Francisco, CA
San Diego, CA
Princeton, NJ

Work Type

Hybrid

Experience Level

10 years of progressively responsible experience in pharmacovigilance operations and or pharmacovigilance quality functions

Education Level

Bachelor’s degree in healthcare, life sciences or a related field

Salary/Compensations

$194,600—$243,300 USD

Benefits

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

About the Company

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.

Equal Opportunity

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 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.