20/09 Career Genesis
HR at Career Genesis

Views:629 Applications:21 Rec. Actions:Recruiter Actions:1

Senior Manager/DGM/GM - Signal Detection - Pharmacovigilance (10-17 yrs)

Ahmedabad Job Code: 4442

- 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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