Senior Manager DSRM (Medical Reviewer)

Long Description

Oversight and management of Medical Review and Signal Management related activities

Medical Review of Health Hazard Assessment and Knowledge sharing and training of DSRM team as required

Signal detection and evaluation activities and Aggregate reports

Medical review and approval of Individual Case Safety Reports and Providing inputs for MR Post Procedure Quality Check (PPQC)

 Review of relevant literature articles for aggregate reports and signal activities

 Supporting team in preparing device malfunction report and drafting response for Health Authority request

Review of Quality investigation reports and Review and approval of case deletion form

 Review of any pharmacovigilance documents after relevant training as required and Provide inputs for SOPs and other guidance documents preparation

Competencies

Education

Work Experience

5 to 10 years of Pharmacovigilance experience with preferred expertise in aggregate report, signal detection, clinical safety/SAE management