Manager - Medical Reviewer (MBBS/MD Only)

Role & responsibilities

• Provide timely support for medical assessment of initial case triage and also assist in reviewing medical information queries pertaining to ICSRs. • Able to properly rank event based on seriousness criteria, labeling and causality assessment • Causality assessment for all events based on WHO algorithm and ICH guidelines also taking into consideration vendor conventions specific for different therapeutics areas. • Able to give proper labeling assessment for adverse events with reference to different types of product safety. • Use of global safety database (ARISg, ARGUS) in accordance with company SOPs and regulatory requirements and draft a medical expert or pharmacovigilance comment. • Medical review of all codings done by using MedDRA (latest version) with respect to adverse events, indications, laboratory data, medical history or surgical procedures. • Should be able to resolve and also raise any medically significant follow up Query or medical relevant Query for respective ICSRs to designated vendor/client. • Training new associates in pharmacovigilance processes in medical relevant topics like causality/labeling/Medical assessment/Medical review as and when required. • Should also help Vendor in resolving any regulatory medical queries or findings pertaining to ICSR reports • Must be able to review, identify potential signals from ICSRs and provide adequate expertise in management of that signal by intimating the vendor. • Would be an active part of any vendor related AUDITs, safety committee meetings and be responsible for any medical review relevant activities. • Should maintain all medical relevant trackers /Minutes of meetings/training records on a real time basis. • Other duties as assigned by the designated reporting manager

Key Competencies:

• Proficiency in ICSR. • Well versed with technical writing requirements for US and EU. • Ability to effectively work independently, prioritize, multi-task and meet established deadlines.