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
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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