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 to regulatory authority inquiries regarding safety issues Qualifications MBBS / MD (Pharmacology, Internal Medicine, or equivalent) Mandatory Minimum 2-5 years of experience in pharmacovigilance or clinical safety Prior experience in medical review of PV cases and signal management preferred Familiarity with ICH-GCP , MedDRA , WHO-ART , and global regulatory guidelines Experience with Argus / ARISg or other PV databases is a plus Excellent written and verbal communication skills Interested to apply can share CV or call/WhatsApp to 9342735755

Posted 1 month 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 Management Plans (RMPs) , Safety Data Exchange Agreements (SDEAs) , and PV SOPs . Guide implementation of PV systems and databases (e.g., Argus, ArisGlobal, Veeva Vault Safety). Lead PV input for due diligence, licensing, and product launches . Qualifications MBBS / MD / PharmD / PhD / MPharm / BDS (mandatory depending on regulatory scope) Additional certifications in GVP, ICH-GCP, Drug Safety, or PV Compliance are preferred Proven experience with regulatory authority interactions , inspections, and PV audits. Interested to apply can share CV or call/WhatsApp to 9342735755

Posted 1 month ago

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