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 final case versions for submission to regulatory authorities. Collaborate with medical writers, PV associates, and biostatisticians on aggregate report contributions. Participate in signal detection and risk assessment meetings (as required). Ensure compliance with global pharmacovigilance regulations (e.g., ICH E2E, GVP). Eligibility / Qualifications: MBBS / BDS / BPharm / PharmD / MPharm / BHMS / BAMS with relevant PV training. Minimum1- 4 years experience in pharmacovigilance or clinical safety (mandatory for mid-level). Strong understanding of clinical trial protocols, GCP, MedDRA, and WHO-DD. Hands-on experience with PV databases like Argus , ARISg , or equivalent. Interested to apply can share you CV in Whatsapp/Call to 9342735755

Posted 1 month 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 clinical trial protocols, study reports, and regulatory submissions Collaborate with internal and external stakeholders to assess and manage safety risks Participate in safety signal detection and assessment activities Contribute to the development and implementation of risk management plans Provide medical review of adverse event reports and ensure timely reporting to regulatory authorities Skills and Qualifications Medical degree (MBBS/MD) with 3-8 years of experience in medical safety or pharmacovigilance Knowledge of global regulatory requirements and guidelines related to drug safety Experience in safety surveillance and risk management activities Excellent analytical and problem-solving skills Ability to work independently and collaboratively in a cross-functional team environment Strong communication and interpersonal skills Attention to detail and ability to manage multiple tasks simultaneously Experience in conducting safety reviews of clinical trial protocols, study reports, and regulatory submissions

Posted 2 months ago

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