Sr. Medical Safety Advisor

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 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 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 postmarketing 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 expectednsess labeling list RSIs etc for the assigned products and develop such additional capabilities within the team Lead drive and participate in training activities product transitions audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract as applicable Attend project meetings medical safety team meetings and represent safety and clinical data review findings during client meetings as applicable Act as Lead Safety Physician or additional team support and or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts e g strategy meetings etc as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req Three 3 years experience practicing clinical medicine after award of medical degree Graduate and or Residency training can qualify for clinical practice experience Req Two 2 years of pharma experience Pref 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 Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures SOPs Skill in use of multiple safety databases Adequate Computer skills especially Microsoft word excel PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers co-workers investigative site staff clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers managers and clients A valid medical license or equivalent from the country or region in which he she resides and works Pref IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide Learn more at