We are looking for an Associate Medical Safety Director to provide medical, scientific and therapeutic expertise on pharmacovigilance services. Participates in all aspects of the Medical Safety activities as per scope of work. This includes, but is not limited to providing and maintaining of PV and risk management expertise to internal and external stakeholders, maintaining knowledge relevant to allocated product portfolios, conducting medical evaluation of post-marketing adverse drug reactions, review and contribution to signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, preparation, and/or contribution to responses to questions from health authorities, reviewing and contributing to periodic aggregate reports, contributing to safety review of study protocols, investigators brochure and other reference safety information, and serving as an internal consultant for any medical support for pharmacovigilance operations.This role can be conducted either Office based / Hybrid / Home based in South Africa - the choice is yours.Role responsibilities:Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profileLeads signal detection and analysis, including signal detection strategy, frequency, and timing, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports presentations of signal evaluation data as appropriateProviding medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic ReportsProviding medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation StrategiesReview and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set upProviding safety oversight and contribution for label development, review, and updatesProvide medical safety contributions to the Integrated Safety Summary or Common Technical DocumentPerforming 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 and serve as an internal consultant to pharmacovigilance case processing teamsRepresenting safety and clinical data review findings during internal and external stakeholder meetingsProviding medical safety support, contribution, and attendance at Safety Governance and other Meetings as neededDo you have the skills, experience and qualification required for the role:A medical degree from an accredited and internationally recognized medical schoolAround three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experienceKnowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research processMaintain knowledge of assigned product portfolio, therapeutic area, and recent literatureExperience in Signal detection, Aggregate reports and Risk management.Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writingAbility to establish and meet priorities, deadlines, and objectivesDemonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needsAbility to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if neededIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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