Medical Safety Assessments and ESP Engagement Manager

About the role

The Medical Safety Assessments and ESP Engagement Manager leads the day‑to‑day operations of safety assessments and external service provider (ESP) collaborations, ensuring high‑quality delivery, regulatory compliance, and operational excellence across global pharmacovigilance activities.

Key responsibilities

• Lead and oversee daily MSA & EE operations, guaranteeing timely and quality delivery of safety and operational tasks.
• Drive compliance, inspection readiness, and adherence to global pharmacovigilance regulations, quality standards, and internal procedures.
• Act as deputy for Group Leads, participating in governance, MRQC arbitration, decision‑making and operational oversight.
• Provide leadership for strategic initiatives, managing deliverables, timelines, risk mitigation and business continuity.
• Support safety deliverables for PVA 3 and PVA 4 compounds, ensuring effective execution and stakeholder alignment.
• Identify and implement continuous process improvements to boost efficiency, quality and compliance.
• Monitor performance metrics, address risks, conduct effectiveness checks and apply corrective actions.
• Support pharmacovigilance audits and inspections as a Subject Matter Expert, handling audit findings.
• Collaborate with external service providers and cross‑functional teams through governance forums, training and performance management.
• Partner with Quality and Clinical Quality teams to implement Quality Plans and close CAPAs arising from audits and inspections.

Required profile

• Advanced degree in Healthcare/Life Sciences (MD, MBBS, MSc, PharmD, PhD) preferred.
• Minimum 10 years of experience in Drug Safety, Pharmacovigilance operations or Project Management.
• Proven ability to lead large, cross‑functional global initiatives.
• Results‑oriented, proactive and quality‑focused with strong communication and stakeholder management skills.
• Demonstrated leadership capabilities including mentoring, negotiation, conflict resolution and decision‑making.

Required skills

• Pharmacovigilance
• Drug safety processes
• Project management