Principal Drug Safety Physician
2 weeks ago
**Job Purpose**:
Principal Safety Physician is responsible for performing medical & safety monitoring tasks in the assigned
projects and contribute to medical review, analysis and guidance in all required safety reports. Principal
project teams, business development and pre-award activities.
- 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
- 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 advice/input for narratives written for Clinical Study Reports (CSRs)
- 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, Safety Evaluation Reports (SERs), Clinical Overview (COs), Clinical Expert Statement, Investigator notification letters
- Function as pharmacovigilance representative/safety scientist
- ** Knowledge and Experience**:
Relevant experience in Pharmacovigilance/ drug safety is desirable.
Experiences into relevant field is preferred.
- ** Education**:
Graduation/Post Graduation in Medicine.
**Job Location**:
- Chandigarh/Mohali/Hyderabad/Homebased
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