Operations Specialist Mgr
Core
Review, assess, and process safety data and information across service lines, including regulatory reporting, safety operations, and adverse event intake.
Role type
Operations Specialist Manager (Pharmacovigilance)
Builds
Safety data processing, regulatory reports, and operational project oversight for life sciences clients
Domain
Life Sciences / Pharmacovigilance
Required skills
Pharmacovigilance activities, Adverse Event (AE) processing, regulatory reporting, case closure, database entry, project management, team mentoring, SOP adherence, stakeholder liaison
Preferred skills
Medical terminology expertise, lifecycle safety systems knowledge, process efficiency implementation, multi-project management
Technologies
Safety databases, Microsoft Office, web-based applications, Lifecycle Safety Systems
Responsibilities
Process safety data per regulations and SOPs, determine event status and reportability, coordinate translations and case closure, act as functional lead for operational projects, mentor junior staff, liaise with regulatory authorities and stakeholders, ensure compliance and quality standards
Seniority
Mid-level Manager, hands-on IC with team oversight
