Director, Global PV Management

The role

The Director, Global PV Management assesses regional and international pharmacovigilance regulatory requirements. This person translates these requirements into drug safety and pharmacovigilance procedures and operational processes.

What you will do

• Review and interpret international and regional pharmacovigilance regulatory requirements
• Monitor changes to pharmacovigilance requirements in operating countries
• Assess pharmacovigilance requirements for new countries and develop readiness plans
• Conduct and document gap assessments between regulatory requirements and existing SOPs
• Lead the development and revision of pharmacovigilance procedures
• Collaborate with the QPPV and local country pharmacovigilance responsible persons
• Translate regulatory requirements into operational steps and timelines
• Coordinate procedure review and implementation
• Maintain a centralized record of requirements, gaps, and implementation status
• Support inspection readiness and responses to findings

Required qualifications

• Bachelor’s degree in healthcare, life sciences or a related field
• 10 years of progressively responsible experience in pharmacovigilance operations and or pharmacovigilance quality functions
• Working knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, MHRA, PMDA, Heath Canada)
• Knowledge of industry best practices (ICH E2E, GVP modules)
• Experience representing PV in quality audits and inspections, including CAPA implementation
• Proficiency in creating and maintaining quality systems, performance metrics, and SOPs
• Proficiency in pharmacovigilance databases, quality systems, and training platforms
• Ability to travel independently overnight

Nice to have

• Experience preferably in a pharmaceutical or biotech environment

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 for underserved neurological and rare disease communities. Their commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome.