Global PV Operations Director

Acadia Pharmaceuticals; South San Francisco (CA); Hybrid; USD 195,000 - 243,000; Full time

Benefits offered by this job

Competitive base, bonus, new hire and–

Employer-paid life, disability, travel

401(k) Plan with a fully vested match

Employee Stock Purchase Plan

Paid time off 15+ vacation days

13-15 paid holidays

Tuition assistance

Job summary

Acadia Pharmaceuticals seeks a Director, Global PV Management to oversee regional and international pharmacovigilance requirements and translate them into operable DSP procedures and processes. You will monitor regulatory changes, assess PV needs for new markets, and drive scalable protocols with cross-functional teams.

The role involves collaboration with QPPV, Regulatory, Quality, Medical Safety, and other stakeholders to ensure ongoing compliance, inspection readiness, and continuous

Qualifications

• 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 pharma/biotech

Responsibilities

• Review and interpret international pharmacovigilance requirements and assess impact on procedures and outsourced activities
• Monitor changes to pharmacovigilance requirements in countries where the company operates
• Assess PV requirements for new countries and develop readiness plans with timelines
• Conduct gap assessments comparing regulatory requirements with SOPs and practices
• Lead development and revision of pharmacovigilance procedures with cross-functional teams
• Collaborate with QPPV and country PV leads to assess country-specific requirements
• Translate regulatory requirements into actionable steps with ownership and timelines
• Coordinate procedure reviews and ensure changes are reflected in practice
• Maintain centralized record of requirements, gaps, owners and documents
• Evaluate SOPs to identify gaps and opportunities for improvement
• Partner to assess adherence to procedures through routine checks and training
• Escalate compliance risks to PV leadership with solutions
• Support inspection readiness and responses to findings
• Other responsibilities as assigned

Skills

PV regulations

PV audits

SOP development

Cross-functional

Documentation & training

Regulatory gap assessments

Process improvement

Travel flexibility

Education

Bachelor’s degree

Tools

PV databases

Quality systems

Job description

Acadia Pharmaceuticals seeks a Director, Global PV Management to oversee regional and international pharmacovigilance requirements and translate them into operable DSP procedures and processes. You will monitor regulatory changes, assess PV needs for new markets, and drive scalable protocols with cross-functional teams.

The role involves collaboration with QPPV, Regulatory, Quality, Medical Safety, and other stakeholders to ensure ongoing compliance, inspection readiness, and continuous