Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07248 About our client Our client is a successful biopharmaceutical company headquartered in New York that is focused on the development and commercialization of innovative products with a wide variety of applications for human health. The management team and board are world class, and the company has both a marketed product in addition to multiple highly promising compounds in clinical trials. This is a unique opportunity for an executive that wants to put their drive and initiative to work in an entrepreneurial setting. Position Location Director/Associate Director, Drug Safety NY Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the safety strategy during drug development 2) Develop and maintain patient risk management plans 3) Recognize and manage safety signals 4) Ensure the appropriateness of user information with respect to safety 5) Contribute significantly to the global knowledge 6) Understand safety of assigned products 7) Act as a safety specialist on one or more project teams 8) Understand corporate safety processes and clinical development processes 9) Educate the clinical development team on department processes 10) Provide comments consistent with department guidelines and clinical safety issues 11) Support the clinical or product team in monitoring a trial 12) Perform database reconciliation activities 13) Review, investigate, track, data enter and report SAEs/AEs from clinical trials 14) Contribute to the global strategy and the Clinical Development Plan (CDP) for the product from a drug safety perspective 15) Oversee drug safety contribution to periodic safety update reports 16) Oversee patient risk management plans, investigator brochures, clinical trial reports and common technical document (Integrated Summaries of Safety) etc. 17) Advise on safety strategy for key clinical trial designs and protocols 18) Review published drug safety literature, published literature for reporting of single cases 19) Identify other important safety information for inclusion in periodic documents 20) Oversee routine monitoring activities 21) Work with Clinical Operations and Data Management to resolve safety data collection 22) Help maintain and update the department project calendar 23) Facilitate the overall efficiency of the department 24) Develop, maintain and expand medical/scientific and regulatory knowledge required to support drug safety activities 25) Assist the pharmacovigilance team in assessment of the overall benefit/risk of products Requirements 1) MD 2) 5 - 7 years of experience in a similar role 3) Understanding of the regulatory environment in which drug safety operates 4) Knowledge of FDA and ICH guidelines 5) Ability to give medical and clinical judgment or to seek a specialist or expert advice 6) A highly motivated individual with the innate ability to work under strict timelines with strong leadership skills 7) Ability to work with individuals at remote locations 8) Verbal and written communication skills 9) Detail-oriented 10) Computer experience/knowledge with drug safety databases
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