Description
Purpose: Provides medical oversight for the pharmacovigilance, drug safety and risk management functions for investigational and marketed products. Ensures proactive and timely risk-benefit assessments of safety data. Ensures successful implementation, execution and maintenance of safety-related strategies, processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations. This role provides an outstanding opportunity to collaborate with colleagues from Clinical Science, Clinical Operations, Biometrics, Project Management, Regulatory & QA, Commercial, IT, Finance and Legal.Requirements: 5-6 years of relevant pharmaceutical industry experience with 1-2 years in pharmacovigilance in a medical or operational position. Preferably both pre- and post-marketing experience. Experience in developing and implementing risk management strategies and plans.
Education: M.D. required with board certification or board eligibility. Specialization and/or experience in oncology or hematology preferred.
Expert knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments. Extensive knowledge of principles of clinical assessment of adverse events in the pharmaceutical industry. Expertise in MedDRA dictionary with relevance to adverse event coding. Experience in working with software based drug safety systems, preferably the ARISg safety database.
To find out more about Real please visit www.realstaffing.com