Drug Safety Physician @ PAREXEL,HYDERABAD "P"

Essential Function
• Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse 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

Education
• Physician (MBBS)
• Medically qualified in an acknowledged Medical School with completion of at least a basic training in clinical medicine (residency, internship etc.)

Language Skills
• Fluent English

Qualifications :
• Experience in Pharmaceutical Medicine desirable
• 1-2 years of PV /CT experience preferred
• Clinical practice experience desirable

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