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Senior Manager DSRM (Medical Reviewer)

Senior Manager DSRM (Medical Reviewer)

Lupin

5 - 10 years

7 - 11 Lacs

Mumbai

Posted:5 days ago| Platform:

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Skills Required

Training Literature Quality check Process excellence Investigation Pharmacovigilance Management Stakeholder management

Work Mode

Work from Office

Job Type

Full Time

Job 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

2. Innovation & Creativity

5. Result Orientation

4. Developing Talent

6. Process Excellence

7. Collaboration

8. 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

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