Senior Medical Safety Advisor Vijayapura

Role: Senior Medical Safety Advisor

Total Experience: 5+ Years.

Pharmacovigilance/PV Experience: 1+ Years

Work location & Mode : PAN India -Homebased

Education: MBBS/MD Graduates.

Must Have Skills: Pharmacovigilance, ICSR.

Job Overview

The 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 responsible 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.

Essential Functions

Perform 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

Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements

Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet 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, as applicable

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 prod Apply on Kit Job: kitjob.in/job/4mfsov