Post Marketing Safety Expert (PSE) - CNS/IM - (Job Number: 0807503)

Post Marketing Safety Expert (PSE) - CNS/IM - (Job Number: 0807503) DescriptionJohnson && Johnson Pharmaceutical Research && Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. Under the oversight of and delegation from the QPPV and deputy QPPV translates the strategy and oversees the execution of the pharmacovigilance activities associated with the Risk Management Plans, Ad-hoc regulatory response, and safety reviews by pharmacovigilance matrix teams. The Post Marketing Safety Expert owns the post-marketing safety plans and will review Post Authorisation Safety Studies for medical importance to the safety profile of the product. Oversees development of safety labeling. On behalf of QPPV office, Review and sign off aggregate reports prepared by the Safety Sciences group. Make recommendations on actions required to maintain a positive risk benefit for products, such as labeling changes. Participate in the preparation and sign-off of other documents relating to product safety. Work with teams from other Johnson and Johnson functions and licensing partners on assessment of safety issues. PRINCIPAL RESPONSIBILITIES: Assess the safety and the risk benefit of assigned authorised products, working with other functional groups within BRM and J&&J as required. Review and sign-off aggregate reports from the Safety Science group for regulatory authority submissions. Review and sign-off other documents relevant to the safety of assigned products such as Risk Management Plans and updates. Advise on the appropriate strategy for regulatory authority submissions and assessments. Provide medical input on franchise area to other functions in BRM such as Integrated Operations personnel.Advise on the suitability of licensing and acquisition candidates. Advise on health implications of quality issues and recommendations for action. DECISION-MAKING AND PROBLEM-SOLVING: Strategy for safety and risk benefit assessment for assigned authorised products. Recommendations for safety related actions required. Represent franchise on Labeling Working Group (LWG) for assigned products. Review and signatory for assessment documents for assigned products. Recommendations on interactions with regulatory authorities. Recommendations for licensing and acquisition candidates. Recommendations for action in relation to product quality issues. A minimum of a Medical Degree (MD or equivalent) is preferred. A doctorate degree (PhD, PharmD) will also be considered. A minimum of 4 years of industry experience is required with at least 2 of those years in safety/pharmacovigilance. Project Management experience is preferred as well. A sound knowledge of regulatory requirements for pharmacovigilance globally is required. Good written and verbal communication skills are required as well as strong team member skills. Time management and the skills to prioritize duties are required. Must also be able to travel up to 10%. If you want to explore the many small-company environments behind the big-company impact of the Johnson && Johnson Family of Companies, bid on this position today! Apply Now