ERGOMED
Biotechnology • Pharmaceuticals • Healthcare Insurance
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
Executive Vice President, PV Operations
Job not on LinkedIn
September 13
ERGOMED
Biotechnology • Pharmaceuticals • Healthcare Insurance
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
đź“‹ Description
• Provide strategic direction for global PV operations, aligning with corporate goals and regulatory expectations • Develop and implement operational strategies for expansion of Safety and Pharmacovigilance services (revenue, operational margins, resources) • Lead, mentor and develop PV operational teams fostering accountability and high performance • Partner with Enterprise PMO/BPO to realise value creation plan (VCP) objectives and drive transformation • Represent PV operations at senior/executive management meetings and governance boards • Accurately forecast resource needs and allocate resources accordingly • Define KPIs and monitor team performance and operational dashboards • Champion operational excellence, standardisation, harmonisation and inspection readiness • Optimise processes through automation, AI-supported case processing and technology adoption • Drive change management and lead process improvement initiatives • Collaborate cross-functionally with Regulatory Affairs, Quality, Medical Affairs and Clinical Development to embed safety insights
🎯 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 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
🏖️ Benefits
• 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 • Diversity, equity, and inclusion and equal opportunities workplace • Investment in staff via an excellent training and development platform • Focus on employee experience, well-being and mental health; healthy work life balance
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