Medical Reviewer (ICSR & AR)

Essential Functions - 

• Perform medical review of Individual Case Safety Reports (ICSRs) in accordance with ProPharma Standard Operating Procedures and Work Instructions.
• Determine event-level causality for applicable reports.
• Generate company comments for select reports. 
• Serve as a case review resource for Pharmacovigilance staff as needed (e.g., seriousness assessment of ICSRs). 
• Participate in the development of departmental policies and procedures and client-specific documents (e.g., Expected Terms List) as needed.
• Provide expert medical safety analysis for periodic safety aggregate reports (e.g. DSUR, PSUR/PBRER, PADER, biologics, bridging reports, Signal reports, Health authority requests/queries, and other relevant aggregate reports.
• Provide medical safety expert opinion for the Signal detection process and risk management activities.
• Provide a medical review of scientific Literature articles/abstracts along with expert or company comment 
• Must be able to assess and identify safety risks and potential signals in safety reports or from designated RSI of suspect products. 
• Must be able to perform accurate labeling assessment wherever required for periodic safety reports.
• Must be able to handle all medical-relevant queries and address medical-related issues from health authority queries/Vendor queries related to aggregate reports or Signal detection reports. 
• Must regularly Liaise with peer medical reviewers and also with vendor medical reviewers in assessing expert outcomes or opinions for all Safety reports. 
• Providing oversight for overall Pharmacovigilance (PV) and medical affairs for relevant medical products. 
• Must be able to take up any additional PV activities as delegated by the reporting manager relevant to the functionality of process or project at an organization 
• Would be an active part of any vendor-related AUDITs, and 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.
• Provides training to pharmacovigilance associates or newly joined medical reviewers on medical-relevant topics, as and when required. 
• Should be able to conduct medical-relevant knowledge sessions to the entire team as and when required on medical-relevant topics related to underlying indications or medical disorders in discussion

Education Required:

• MBBS/MD

Experience:

• 2+ Years of professional experience.
• Experience in ICSR Medical Review and Aggregate reports review (PSUR/PADER/PBERER/Signal Detection/RMP)