Senior Medical Safety Advisor

Job Description

Role: Senior Medical Safety Advisor\nTotal Experience: 5+ Years.\nPharmacovigilance/PV Experience : 1+ Years\nWork location & Mode : PAN India -Homebased\nEducation : MBBS/MD Graduates.\nMust Have Skills: Pharmacovigilance, ICSR.\n\nJob Overview\n\nThe objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.\n\nEssential Functions\n\nPerform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary\nCompose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements\nProvide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, o