Pharmacovigilance Services Specialist
Core
Managing drug safety surveillance, case identification, data entry, MedDRA coding, and ICSR processing for pharmacovigilance clients.
Role type
Senior Medical Review Scientist (Pharmacovigilance)
Builds
Safety databases and regulatory submissions for pharmaceutical clients
Domain
Healthcare / Life Sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance operations, Drug safety surveillance, Case processing, MedDRA coding, ICSR management, Regulatory compliance, Mailbox reconciliation, Team management
Preferred skills
Strategic direction alignment, Method adaptation, Client interaction
Technologies
Safety databases, MedDRA
Responsibilities
Manage affiliate mailbox reconciliation for serious and non-serious cases, Create and manage case identification and data entry, Perform MedDRA coding and case submission, Solve moderately complex drug safety problems, Manage small teams or work efforts
Seniority
Senior, hands-on IC with team management