Medical Reviewer

Job Description:

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 profiles like USPI, Canadian Product Monograph, SmPC, CDS, PIL, PI, RSI.

• 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.

Qualification & Experience

• Required: Valid Medical degree (MBBS, BDS with experience) from a centrally recognized University/college (MCI recognized)

• Preferred: 1-2 years of experience in related field of expertise.

• Preferred: Database experience of ARISg/ARGUS.

• Preferred: Experience in handling Medical queries/trainings in PV.

• Preferred: Experience in ICSR process with expert knowledge on MedDRA codings, IME list, CTCAE table.

• Proficient with Microsoft Office Suite (Outlook, Word, Excel).