Medical Safety Physician CLIN BIOSCIENCES
CLIN BIOSCIENCES
Office Location
Full Time
Experience: 2 - 2 years required
Pay: INR 800000 - INR 1600000 /year
Type: Full Time
Location: Bangalore
Skills: Risk management, Signal Detection, Regulatory Compliance, Pharmacovigilance, aggregate reporting, medical safety review, drugsafetyindia
About CLIN BIOSCIENCES
Job Description
Roles and Responsibilities
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Perform medical review of Individual Case Safety Reports (ICSRs), Serious Adverse Events (SAEs), and SUSARs
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Conduct causality and seriousness assessments of adverse events
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Validate case narratives and ensure medical accuracy and regulatory compliance
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Participate in safety signal detection and risk evaluation
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Contribute to the preparation and review of aggregate reports: PSUR, PBRER, DSUR, RMP
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Support updates to product safety labels (SmPC, PI) based on current safety data
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Collaborate with regulatory, clinical, and medical affairs teams for cross-functional safety activities
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Provide clinical input on global pharmacovigilance strategies and safety documents
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Respond to regulatory authority inquiries regarding safety issues
Qualifications
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MBBS / MD (Pharmacology, Internal Medicine, or equivalent) Mandatory
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Minimum 2-5 years of experience in pharmacovigilance or clinical safety
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Prior experience in medical review of PV cases and signal management preferred
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Familiarity with ICH-GCP, MedDRA, WHO-ART, and global regulatory guidelines
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Experience with Argus / ARISg or other PV databases is a plus
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Excellent written and verbal communication skills
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Interested to apply can share CV or call/WhatsApp to 9342735755