Medical Safety Physician CLIN BIOSCIENCES

2.0 - 5.0 years

0 - 0 Lacs

bangalore, noida, hyderabad

On-site

Roles and Responsibilities Perform medical review of Individual Case Safety Reports (ICSRs) , Serious Adverse Events (SAEs), and SUSARs Conduct causality and seriousness assessments of adverse events Validate case narratives and ensure medical accuracy and regulatory compliance Participate in safety signal detection and risk evaluation Contribute to the preparation and review of aggregate reports : PSUR, PBRER, DSUR, RMP Support updates to product safety labels (SmPC, PI) based on current safety data Collaborate with regulatory, clinical, and medical affairs teams for cross-functional safety activities Provide clinical input on global pharmacovigilance strategies and safety documents Respond...

Posted 4 months ago

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Head Drug Safety CLIN BIOSCIENCES

5.0 - 10.0 years

0 - 0 Lacs

bangalore, noida, hyderabad

On-site

Roles and Responsibilities Lead global and local PV teams including medical reviewers, case processors, and safety scientists. Oversee ICSR management, medical assessments, signal detection , and aggregate report submissions (PSUR, PBRER, DSUR). Define and implement company-wide drug safety strategy aligned with regulatory expectations (CDSCO, EMA, FDA, MHRA, PMDA). Ensure full compliance with global PV regulations , including GVP Modules, ICH E2E/E2D , and local Indian guidelines. Liaise with Regulatory Affairs, Medical Affairs, Quality, Clinical, and R&D functions. Represent the company in regulatory inspections, audits , and safety governance boards . Review and sign-off on Risk Managemen...

Posted 4 months ago

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