Senior medical safety advisor

Role: Senior Medical Safety AdvisorWork Experience: 5+ Years.Clinical Experience: 3+ Years.Pharmacovigilance/PV Experience: 2+ YearsWork location: PAN IndiaWork Mode: Home BasedMust Have Skills: Pharmacovigilance, ICSR.Job OverviewThe 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.Essential FunctionsPerform 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 summaryCompose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirementsProvide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical dataServe as an internal consultant to pharmacovigilance case processing teams on projects being supportedPerform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicableProvide 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 (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective.Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.Ensure update of watch list, list of expectedness, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the teamLead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiativesReview and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicableAttend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicableAct as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicableProvide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable24-hour medical support as required on assigned projectsMaintain awareness of medical safety-regulatory industry developmentsProvide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicableQualificationsMBBS OR MD from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is required.Three plus (3 + years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training is required.Two plus (2+) years of pharmacovigilance experience is required.Sound knowledge of MedicineIn-depth knowledge of applicable global, regional and local clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesKnowledge of Pharmacovigilance- ICSR.In-depth knowledge of departmental standard operating procedures (SOPs)Skill in use of multiple safety databasesAdequate Computer skills, especially Microsoft word, excel & Power PointGood communication skills- verbal and writtenAbility to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representativesAbility to establish and maintain effective working relationships with coworkers, managers and clientsA valid medical license, or equivalent, from the country or region in which he/she resides and works preferred.