ERGOMED

Executive Vice President, PV Operations

ERGOMED

full-time

Posted on:

Origin:  • 🇭🇷 Croatia

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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 the highest level of 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 terms of revenue, operational margins and resources
  • Lead, mentor and develop PV operational teams; define KPIs and monitor team performance
  • Partner with Enterprise PMO/BPO to realize objectives of the value creation plan and optimize/standardize end-to-end PV processes
  • Drive operational excellence through process mapping, automation, and technology adoption including AI-supported case processing
  • Lead inspection readiness and quality excellence initiatives and foster cross-functional collaboration to integrate safety insights 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