Executive Vice President, PV Operations
ERGOMED
Executive Vice President, PV Operations
ERGOMED
full-time
Posted on:
Origin: • 🇫🇷 France
Visit company websiteJob Level
Lead
About the role
- Lead and oversee all operational aspects of global pharmacovigilance activities ensuring compliance with regulatory requirements, company SOPs, and industry standards
- Manage PV teams, mentor staff and foster a culture of accountability, high performance, and continuous learning
- Develop and implement strategic operational plans for expansion of safety and pharmacovigilance services (revenue, margins, resources)
- Partner with Enterprise PMO/BPO to realize value creation plan objectives and standardize end-to-end PV processes
- Define KPIs, monitor team performance, and leverage metrics to inform management interventions
- Optimize operational frameworks via process mapping, automation, AI-supported case processing and technology adoption
- Drive global harmonization of PV processes across regions, affiliates, and partners and ensure inspection readiness and quality excellence
- Collaborate cross-functionally with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development to integrate safety insights into product lifecycle management
- Accurately forecast resource needs, allocate resources, and engage commercial leadership on process variation and revenue opportunities
- Lead change management initiatives and implement process improvements to enhance efficiency, accuracy, reporting timeliness, and signal detection performance
Requirements
- Ideally an Advanced degree
- 15+ years of pharmacovigilance experience
- 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 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
- High attention to detail and strong analytical skills
- Experience with operational KPIs, forecasting and resource allocation
- Familiarity with inspection readiness and quality systems
- English proficiency (company language)