Executive Vice President, PV Operations
ERGOMED
Executive Vice President, PV Operations
ERGOMED
full-time
Posted on:
Origin: • 🇪🇸 Spain
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, optimize operational processes, and collaborate cross-functionally to ensure patient safety and product quality
- Optimize cost, speed and quality of delivery through leveraging metrics to inform management interventions
- Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations
- Develop and implement strategic plans for expansion of Safety and Pharmacovigilance services in revenue, operational margins and resources
- Lead, mentor, and develop PV operational teams, fostering a culture of accountability and high performance
- Partner with Enterprise PMO/BPO to realize the objectives of the value creation plan (VCP)
- Represent PV operations at senior/executive management meetings and governance boards
- Define KPIs and monitor team performance
- Champion operational excellence and continuous improvement across global PV operations
- Optimize and standardize end-to-end pharmacovigilance processes, leveraging automation and emerging technologies
- Drive global harmonization of PV processes and lead inspection readiness and quality excellence initiatives
- Lead process improvement, technology adoption, change management and implementation of AI-supported solutions
- Act as strategic bridge between PV Operations and internal stakeholders, embedding safety intelligence into product lifecycle management
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
- Strategic leadership and decision-making
- Operational excellence and process improvement
- Regulatory compliance and risk management
- Cross-functional collaboration
- High attention to detail and analytical skills