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
- Innovation & Creativity
- Result Orientation
- Developing Talent
- Process Excellence
- Collaboration
- Stakeholder Management
Education
Doctorate
Graduation in Medicine
Work Experience
5 to 10 years of Pharmacovigilance experience with preferred expertise in aggregate report, signal detection, clinical safety/SAE management 
