Associate Manager - Safety Operations
Core
Leading and overseeing local/regional pharmacovigilance operations, ensuring effective delivery of safety activities, ICSR surveillance, and compliance with regulations and Sponsor requirements.
Role type
Senior IC safety operations manager (pharmacovigilance)
Builds
Safety operations and ICSR processing services for pharmaceutical sponsors
Domain
Life sciences / Pharmacovigilance
Required skills
Pharmacovigilance operations management, ICSR surveillance and intake, team leadership and performance management, regulatory compliance oversight, stakeholder and Sponsor communication, risk identification and escalation, quality assurance and CAPA management, workload and capacity planning
Preferred skills
Third language proficiency, experience coordinating global operational teams, Sponsor-facing environment experience
Technologies
Global Safety Database, ICSR reporting systems, translation tools
Responsibilities
Provide day-to-day leadership and operational oversight of assigned direct reports; Serve as primary operational point of contact for the Sponsor; Oversee safety-related operations including ICSR surveillance, mailbox screening, and case intake; Maintain oversight of quality, compliance, and inspection readiness; Monitor operational KPIs, SLAs, and performance trends; Drive continuous improvement initiatives and remediation activities
Seniority
Senior, hands-on IC