Associate Manager - Safety Operations

About the role

The Associate Manager - Safety Operations leads and oversees local and/or regional pharmacovigilance operations, ensuring safety activities are delivered in line with regulations, Sponsor requirements, project procedures, SOPs, quality standards and agreed KPIs/SLAs. The role provides direct leadership of the team and acts as a key operational contact for the Sponsor and project stakeholders.

Key responsibilities

• Lead and supervise direct reports, set expectations, coach and develop them, and balance workload to maintain business continuity
• Monitor Sponsor KPIs, SLAs, quality metrics and compliance, and escalate risks affecting Sponsor commitments, patient safety or regulatory compliance
• Oversee ICSR surveillance, mailbox screening and case intake, and ensure timely creation of case reports for the Global Safety Database
• Follow up with ICSR reporters and reconcile ICSRs with internal functions and licensing partners
• Support quality and compliance, including investigations, CAPA follow-up and audit/inspection readiness
• Work with Sponsor, Quality, Compliance, Training, Regulatory and other functions, and support project governance meetings

Required profile

• Bachelor's degree in Life Sciences or a related scientific/medical discipline, or equivalent pharmacovigilance experience
• At least 5 years of relevant professional experience, including at least 3 years in pharmacovigilance
• Experience coordinating, supervising or leading operational teams is strongly preferred
• Experience in a Sponsor-facing and/or global pharmacovigilance environment is preferred
• A third language is highly valued; proficiency in English and the local/regional language is required

Required skills

• Understanding of global and local pharmacovigilance regulations and guidelines
• Experience with electronic safety databases such as Argus or equivalent
• Strong people leadership, KPI and SLA management, and stakeholder communication skills