Medical Safety Advisor

• 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