About the role
- Responsible for leading and overseeing all operational aspects of global pharmacovigilance activities
- Ensure compliance with regulatory requirements, company SOPs, and industry standards
- Manage PV teams, optimize operational processes
- Collaborate cross-functionally to ensure the highest level of patient safety and product quality
- Define KPIs and monitor team performance
- Champion a culture of excellence across global PV operations
- Collaborate with various PMO teams to optimize and standardize end-to-end pharmacovigilance processes.
- Drive global harmonization of PV processes across regions, affiliates, and partners to ensure consistent execution and regulatory alignment
- Lead inspection readiness and quality excellence initiatives
Requirements
- Ideally an Advanced degree
- 15 + years of pharmacovigilance experience, with at least 10 years in an operational leadership role with P&L responsibilities.
- In-depth knowledge of global PV regulations, GVP modules, and drug safety principles.
- Proven track record of managing PV operations in a global environment within a CRO or PV service provider.
- Strong leadership, project management, and strategic thinking skills.
- Excellent communication, negotiation, and interpersonal abilities.
- Experience with safety databases (e.g., Argus, ArisG) and PV software tools.
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmacovigilanceglobal PV regulationsGVP modulesdrug safety principlesoperational leadershipP&L responsibilitiesproject managementKPI definitioninspection readinessquality excellence
Soft skills
leadershipstrategic thinkingcommunicationnegotiationinterpersonal abilities
Certifications
Advanced degree