Executive Vice President, Pharmacovigilance Operations

Job not on LinkedIn

October 21

🌲 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

• The Executive VP, Pharmacovigilance (PV) Operations is responsible for leading and overseeing all operational aspects of global pharmacovigilance activities, ensuring compliance with regulatory requirements, company SOPs, and industry standards. • This role will manage PV teams, optimize operational processes, and collaborate cross-functionally to ensure the highest level of patient safety and product quality. • Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations. • Develop comprehensive operational strategies that align with the company’s overall objectives. • Lead, mentor, and develop PV operational teams, fostering a culture of accountability, high performance, and continuous learning. • Represent PV operations at senior/executive management meetings, governance boards, and cross-functional leadership forums. • Champion a culture of excellence across global PV operations, embedding best practices, innovation, and continuous improvement to enhance patient safety outcomes. • Collaborate with Enterprise PMO/BPO to optimize and standardize end-to-end pharmacovigilance process. • Drive global harmonization of PV processes across regions, affiliates, and partners to ensure consistent execution and regulatory alignment. • Act as a strategic bridge between Pharmacovigilance Operations and key internal stakeholders, ensuring safety intelligence informs and enhances corporate decision-making.

🎯 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