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Wednesday, 27 November 2013

Drug Safety Physician ''A''

Drug Safety Physician

Job Description 

Job Title Drug Safety Physician
Department Worldwide Medical Services
Event and Adverse Reaction reports received for investigational and marketed products 
Ongoing safety surveillance and signal detection/analysis 
Provide medical guidance to Drug Safety Associates and Specialists in medical aspects of drug safety 
Provide medical input in all required safety reports, such as but not limited to PSURs, Clinical Expert Statement, Investigator notification letters 
Review all documents assigned for scientifically relevant issues including drug safety 
Function as pharmacovigilance representative/safety leader/senior technical lead on the projects, in Proposal Development Team and/or client meetings 
Provide medical advice and support for the safety component of feasibility studies 
Provide safety input to Risk-Management Plans, Pharmacovigilance Strategy and to the overall analysis of the benefit-risk balance of marketed or investigational products 
Support of Medical Directors as required 
Support of the QPPV

                                                                                         

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