Clinical Safety Reviewer CLIN BIOSCIENCES

1.0 - 4.0 years

0 - 0 Lacs

bangalore, chennai, noida

On-site

The Clinical Safety Reviewer (CSR) is responsible for evaluating and interpreting adverse events (AEs), serious adverse events (SAEs), and product safety data collected during clinical trials or post-marketing surveillance. The role ensures scientific and regulatory accuracy in case assessments, contributing to patient safety and regulatory compliance. Roles and Responsibilities; Review clinical safety data including ICSRs, SAEs, and narratives for accuracy and medical completeness. Assess seriousness, expectedness, and causality based on protocol, IB, and regulatory guidelines. Ensure the consistency of MedDRA coding and WHO Drug coding in line with global standards. Review and approve fina...

Posted 4 months ago

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Medical Safety Physician Diensten Tech Limited

3.0 - 8.0 years

4 - 7 Lacs

Gurgaon / Gurugram, Haryana, India

On-site

Description We are seeking a highly motivated Medical Safety Physician with 3-8 years of experience to join our team. As a Medical Safety Physician, you will be responsible for ensuring patient safety and compliance with regulatory requirements. You will work closely with cross-functional teams to develop and implement safety strategies for our products. Responsibilities Develop and implement medical safety strategies for our products Manage safety-related issues and concerns from clinical trials through to post-marketing surveillance Ensure compliance with regulatory requirements and guidelines Provide medical expertise and guidance to cross-functional teams Conduct safety reviews of clinic...

Posted 5 months ago

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