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Lambda Therapeutic Research
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Manager - Medical Reviewer

Manager - Medical Reviewer

Lambda Therapeutic Research

5 - 8 years

|

8 - 9 Lacs

Posted:1 day ago| Platform:

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Skills Required

training cro usage literature clinical research healthcare pharmacology pharmacovigilance management spectrum

Work Mode

Work from Office

Job Type

Full Time

Job Description

Signal detection and management activities: Performing signal detection for client s medicinal product, to assess benefit risk balance of the client s medicinal product.
Interact with signal detection team at various levels and in various functional areas to resolve any issues that arise during reviews and to use more effective methodologies for improvement of efficiency.
Providing input into responses to inquiries from regulatory authorities or health care professionals on safety issues and assist in the training team members.
Literature review for selection of ICSR and article of interest (for signal detection).
Performs comparison of client s label with reference/innovator label and to recommend the changes in client s label.Communication of urgent safety issues to Line manager and QPPV.
Health Hazard assessment report drafting.

EXPERIENCE

5 years of Pharmacovigilance experience or relevant signal detection/PSUR experience.

EDUCATIONAL QUALIFICATION

MBBS/MD Pharmacology

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Lambda Therapeutic Research

Pharmaceuticals / Biotechnology

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