Global PV Compliance Director

ACADIA Pharmaceuticals Inc.

Princeton (NJ)

Hybrid

USD 195,000 - 243,000

Full time

4 days ago
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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

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

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