Medical Safety Leader > Oxford Global Resources > Joboolo BE :
Société : Oxford Global Resources Lieu : Mechelen Flanders Site source : Talent BE
pharmacovigilance, are followed in assigned projectManage the external service providers delivering pharmacovigilance services, up to industry standards as per regulations and guidelines, including financial follow up, quality control of the ICSRs, PSURs and any other Safety related documents, compliance with regulatory requirements (timely submission of expedited and periodic reports)Perform medical review and provide medical advice on safety-related aspects associated with the assigned compoundsChair regular meetings of the Safety Management Teams overseeing the compound Safety profileReview and validate ICSRs from ongoing clinical studies and collaborate with the External service provider to process the ICSR, ensure expedited reporting requirements are metReview of a study-specific Safety Project Plan for assigned clinical studies across the portfolio, and ensure oversight on the activities executed accordinglyIntegrate the safety scientific component to build up a strategic framework for clinical development plansContribute to the creation and review of the Safety parts of certain clinical study related documents - Clinical Study Synopsys/Protocols, Clinical Study ReportContribute to the creation and review of the Safety parts of certain compound related documents - Investigator's Brochure, dRMP, …Initiate, author, oversight and collaborate with the Regulatory Leader to create and submit the Development Safety Update Report (DSURs)RequirementsMD degree or equivalent (eg, DO or MB) required7 years or more of clinical experience and/or Industry experience, with at least 3 years of these in patient safety or pharmacovigilance Previous experience in phase 1 to 3 clinical trials strongly preferredPrior Oncology experience strongly preferred, either in clinical practice or drug safetyImmunology experience would also be beneficial plusExperience with interactions with major Regulatory Agency is preferredEffective team member who takes ownershipDemonstrated attention to detail, strategic thinking and problem solving skillsAble to work under stress, demonstrating initiative and flexibilityExisting right to work in Europe is requiredBenefitsFulltime positionRemoteA balanced salary package based on your capabilities and experience, including extra legal benefitsVacancy number:
