Central Operations Lead - fixed term (PV, Pharmacovigilance)

Central Operations Lead

As a Central Operations Lead within the Patient Safety Operations team, you will leverage your pharmacovigilance expertise to oversee global safety data processing and reporting. You will champion quality, drive process improvements, and lead complex initiatives while ensuring regulatory compliance and integrating innovative tools like artificial intelligence.

Responsibilities

• Oversee service providers by managing relationships and using data-driven metrics for ICSR and Medical Device reporting.
• Provide subject matter expertise to internal colleagues, partners, and regulatory inspectors.
• Lead continuous improvement efforts to simplify workflows and design strategic process enhancements.
• Manage compliance and risks by identifying root causes and implementing corrective and preventative actions.
• Evaluate the impact of evolving international regulatory requirements.
• Lead complex, time-pressured projects across matrix teams.

Requirements

• Deep knowledge of international pharmacovigilance regulations (ICH, EU GVP, FDA) and the pharmaceutical industry.
• Profound understanding of end-to-end ICSR case processing and stakeholder expectations.
• Proven experience in project leadership and managing cross-functional stakeholders.
• Strong analytical problem-solving skills with a history of independent decision-making and risk mitigation.
• Undergraduate degree or equivalent experience with a flexible, learning-oriented mindset.
• Experience with Medical Device processing is considered an advantage.