Senior Pharmacovigilance Expert

2 days ago

guntur, India beBeeMedical Full time

Job Title: Senior Medical Safety AdvisorOverviewThe primary objective of this role is to provide medical expertise in the evaluation of safety data from various sources, as part of the overall pharmacovigilance process. This position plays a crucial part in determining the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile.Key Responsibilities:Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs).Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases based on regulatory requirements.Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify clinical data.Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture.Provide aggregate reviews of safety information, including but not limited to clinical data, post marketing, literature review, and observational studies to maintain oversight of a product's safety profile.QualificationsMBBS OR MD from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.1+ years of pharmacovigilance experience and 5+ years of total experience is mandatory.Sound knowledge of Medicine.In-depth knowledge of applicable global, regional, and local clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

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