Safety Physician (MBBS) | Pharmacovigilance Medical Review

Job Summary

Description Safety Physician (MBBS) | Pharmacovigilance Medical Review | Immediate Joiners Preferred

Responsibilities

• Performs medical review of adverse events reported for investigational and marketed products
• Maintains familiarity with MedDRA, WHO-DRL, and safety databases such as ARGUS.
• Works closely with Safety and Pharmacovigilance (SPVG) colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment
• Ensures regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical and post-marketing safety information
• Identifies, communicates and effectively manages potential safety issues
• Interacts with client's safety/medical personnel as appropriate
• Stays abreast of clinical and drug development information relevant to contracted programs
• Provides medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs)
• Maintains medical and pharmacovigilance expertise through appropriate internal or external continued medical education
• Assists as a mentor and trainer for other internal safety staff including case processing staff
• Responsible for performing activities that are in compliance with applicable Corporate and Departmental Policies, Standard Operating Procedures, Work Instructions and any project specific Operating Guidelines
• Performing other duties as assigned by management.

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