ERGOMED

Executive Vice President, PV Operations

ERGOMED

full-time

Posted on:

Origin:  • 🇨🇿 Czech

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Job 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
  • Provide strategic direction for PV operations and develop comprehensive operational strategies
  • Develop and implement strategic plans for expansion of Safety and Pharmacovigilance services in terms of revenue, operational margins and resources
  • Lead, mentor, and develop PV operational teams and define KPIs and monitor team performance
  • Champion operational excellence, standardize end-to-end pharmacovigilance processes, and optimize workflows through automation and technology
  • Drive process improvement, AI-supported case processing, and change management initiatives
  • Represent PV operations at senior/executive management meetings, governance boards, and cross-functional leadership forums
  • Lead inspection readiness and quality excellence initiatives and foster cross-functional collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development

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