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Manager - Medical Reviewer (ICSR)
2 weeks ago
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.
