Senior Drug Safety Physician
3 weeks ago
Minimum 1 year of experience in safety scientific writing/PSUR/PBRER/Aggregate report/Signal
Provide medical, safety input and review of all required safety reports, such as- but not limited to -
Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Assessment Reports (PBRERs)/
Periodic Adverse Drug Experience Reports (PADERS), Risk Management Plans (RMPs), Benefit
Risk Assessment, Signal Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert
Statement, Investigator notification letters
Job Description
Performing medical review of literature references in accordance with client procedures and
Standard Operating Procedures/regulatory guidelines for the purpose of product safety assessment
Signal detection/analysis/evaluation and ongoing safety surveillance activities
Provide medical guidance and input to Drug Safety associates (DSAs) and specialists in medical
aspects of drug safety
Provide medical, safety input and review of all required safety reports, such as- but not limited to -
Periodic Safety Update Reports (PSURs)/ Periodic Benefit Risk Assessment Reports (PBRERs)/
Periodic Adverse Drug Experience Reports (PADERS), Risk Management Plans (RMPs), Benefit
Risk Assessment, Signal Evaluation Reports (SERs), Clinical Overview (COs), clinical Expert
Statement, Investigator notification letter
Review and authoring of aggregate reports for medical context and
consistency in accordance with client requirements and SOPs
Providing medical advice to case processors for authoring of sections
Training and mentoring new team member, as required
Working as Subject Matter Experts (SMEs)
Assisting the Manager DSP for inspection readiness activities and audits
Provides inputs for process improvisations
#LI-REMOTE
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