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authentic American football jerseys senior role, operating out of Berkeley Heights, NJ member of GDSRM Senior Leadership and of the assigned Celgene Core construction Project Teams, And reporting the Head of Trial Safety surveillance, With a matrix functional broken relationship to the Global Safety Franchise Lead.As a chairman of the assigned product/indication Safety software Team, The Lead Safety Physician is ultimately answerable, in complete agreement with the Franchise Product Lead, For creating tweaking a single interpretation of global safety data for assigned projects of new indications in development for existing drugs, And is responsible on a routine basis for: Identifying and managing safety concerns with assigned projects creating the assigned project safety risk management strategy in agreement with Franchise Lead and in accordance to the Product Franchise overall strategy creating co ordination and leading action across the Global Drug Safety Department providing a robust assessment of developmental product safety upon which marketed new indication safety surveillance may be based F acilitating and chairing internal DMCs, Or providing appropriate safety analyses and public speaking event for external DMCs As core member of the Project team, Prepare and present safety risk management topics to the company key developmental governance bodies as requiredIn agreement with the Product Franchise Lead, The Lead Safety Physician ensure resolution and appropriate communication and inclusion of key issues of safety: Escalate to the Product Franchise SMT and if necessary to the Company Safety Committee Lead the preparation of Core Data Sheet Safety sections for the new indication, Ensuring alignment with the Franchise Lead and contingency Core Data Sheet planned changes. Support the increase of latest updates and findings from ongoing pharmacovigilance and epidemiological analysisThe interaction with regulatory affairs is a vital part of the execution of safety leadership: Review regulatory inquiries, lead generation of relevant safety data, Prepare regulatory responses evaluating the best strategy and strategy agreed with other team members and the Franchise Lead appropriately. Preparation of the safety sections of label, Product leaflets, And other regulatory documents guidance in related face to face regulatory meetings Contribute, Compile and assist in analysis of required safety data and illustrative text for EOP2 Package Pre NDA meetingThe Lead Safety Physician does also: Provide expert advice to Medical Review and provide immediate college hockey jerseys { input to escalated reports as needed; Execute further escalation of central reports within Celgene as needed.