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Senior Drug Safety Physician

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

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 Provide medical monitoring for assigned projects Review all documents assigned for scientifically/medically relevant issues including drugsafety Function as medical representative/technical lead/senior technical lead on the projects, inProposal Development Team and/or client meetings Provide advice and support for feasibility studies Provide support for DMC and CEC managementQualificationsKnowledge and Experience Experience in Pharmaceutical Medicine desirable but not (initially) essential Clinical practice experienceEducation Physician (MBBS/MD) Medically qualified in an acknowledged Medical School with completion of at least a basic training in clinical medicine (residency, internship etc.); or comparable post-graduate experience in clinical research, Pharmacovigilance or regulatory domain.
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: MBBS

Experience: 4-9


Critical Care | Medical Imaging | Medical Officer | Medical Rep.
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