Leading Senior Pharmacovigilance Expert

2 weeks ago

nadiad, India beBeePharmacovigilance Full time

Senior Medical Safety Advisor Job DescriptionThis role provides medical expertise in the evaluation of safety data from various sources as part of the overall pharmacovigilance process.Evaluate and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile.Prepare aggregate reports in collaboration with post-marketing safety experts and safety surveillance group.Job 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 and medically vet clinical data.Essential Functions: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.Required Skills and Qualifications:MBBS OR MD from an accredited and internationally recognized medical school with a curriculum relevant to general medical education is required.1+ years of pharmacovigilance experience and 5+ years of total experience is mandatory.Sound knowledge of medicine, good communication skills-verbal and written, ability to establish and maintain effective working relationships with managers, coworkers, site staff, clients and regulatory agency representatives.Benefits:Maintain awareness of medical safety-regulatory industry developments.Act as lead safety physician or additional team support, provide medical escalation support for medical information and EU qualified persons for pharmacovigilance projects.Others:Prioritize tasks effectively to meet productivity, compliance and quality standards.Ability to work independently and collaborate with others to achieve goals.

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