HR at Career Genesis
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Senior Manager/DGM/GM - Signal Detection - Pharmacovigilance (10-17 yrs)
- Perform signal detection activities (qualitative and the quantitative), validation, confirmation, analysis and the recommended action. based on the regulatory requirements
- Scientific Review of Risk Management Plan.
- Scientific review of feedback provided by PRAC assessment on PBRER and Monitoring issues.
- Involved in QPPV discussion on Risk Identifications and Signa Management
- Review of Signal Tracking Sheet of the required action to be taken for ongoing and closed signals
- Facilitate and Participate in Drug Safety Meetings and Signal Detection management meeting with the QPPV
- Scientific Review of the clinical overview and supporting documents for the CCDS
- To Lead Team in handling the physicians team
- Training to the Medical Reviewers and the authoring team on signal detection, Aggregate report.
- Review & finalize client documents and provide feedback to the case processors and QC reviewers to ensure errors are not repeated.
- Medical Review of Literatures
- To prepare, review and provide comments for SOP and Work Instructions on PBRER and Signal detection documents in collaboration with QA team
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