PHARMAFull-time
Senior Safety Narrative Writer
HYDERABAD (IN)HYBRIDPOSTED: 8/12/2026
PHARMAFull-time
HIRING ORGANIZATIONBRISTOL MYERS SQUIBBPharmaceuticals
BR
ROLE DEFINITION & RESPONSIBILITIES
Author and review high-quality patient safety narratives for Serious Adverse Events (SAEs) from clinical trials.
Extract and synthesize complex clinical trial safety data from Argus, clinical databases, and source medical documents.
Partner with Medical Reviewers, Safety Physicians, and Clinical Study Teams to resolve clinical query discrepancies.
Ensure narrative documents strictly adhere to ICH-E3 guidelines, company SOPs, and international regulatory reporting timelines.
Support regulatory inspection readiness and perform quality checks on patient safety documentation deliverables.
REQUIRED VERIFIED SKILLS
Safety Narrative Writing
Pharmacovigilance
Clinical Trial Safety
Argus
ICH-E3 Guidelines
Medical Writing
SAE Reporting
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Bristol Myers Squibb is actively hiring for this position.
INDUSTRY: Pharmaceuticals
RECOMMENDED TRAINING
1/5
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