Medical Reviewer

Job Description

Role & responsibilities :- Candidate is primarily responsible for but not limited to: 1) ADR case triage and validity assessment: Perform triage of ADR cases for seriousness/follow up significance and identification of suspect products and events. Perform ADR case validity assessment. 2) Adverse Drug Reaction (ADR) processing Perform medical review of ICSRs Review of Literature Alerts and Medical Information Perform event listedness assessment to enable expedited reporting of ICSRs as per applicable regulatory requirements 3) Periodic Safety Report generation Medical Review of Periodic safety reports Medical review of line listings, query response, case correction. 4) Risk management Plan Preparation of Risk Management Plan 5) Other Pharmacovigilance projects Work in any other assigned Pharmacovigilance project Ensure compliance to applicable SOPs Maintenance of personal Pharmacovigilance record as per the applicable SOP Skills : Good Communication Skills, Awareness of global drug safety guidelines, sound medical knowledge, workflow management