Executive Vice President, PV Operations

Job not on LinkedIn

September 12

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

⏰ Full Time

🔴 Lead

⚙️ Operations

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ERGOMED

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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.

1001 - 5000 employees

Founded 1997

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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 comprehensive operational strategies 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 represent PV operations at senior/executive management meetings and governance boards • Define KPIs and monitor team performance and collaborate with Enterprise PMO/BPO to standardize end-to-end pharmacovigilance process • Drive global harmonization of PV processes, lead inspection readiness and quality excellence initiatives, and foster cross-functional collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development • Drive operational excellence through process mapping, automation, and technology adoption, and lead change management initiatives to adapt PV operations

🎯 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

🏖️ 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