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If you’re aiming to advance your career in pharmacovigilance (PV) and global drug safety, this Senior Specialist, International Patient Safety job in Hyderabad is a high-impact opportunity.
Bristol Myers Squibb is hiring skilled professionals to support risk management plans (RMP), ICSR processing, aggregate reports, and global PV compliance activities. This role offers exposure to international safety regulations (ICH, CIOMS) and cross-functional collaboration across global markets.
This position is ideal for candidates with 1โ2 years of pharmacovigilance experience looking to transition into global safety operations and strategic PV roles.
๐ Key Responsibilities โ Patient Safety & PV Role
- Support development and maintenance of Risk Management Plans (RMPs)
- Perform ICSR (Individual Case Safety Report) processing, literature screening, and submissions
- Manage safety mailbox and PV communications
- Assist in aggregate reporting (PSUR, DSUR support)
- Maintain PV System Master File (PSMF) and ensure data quality
- Support pharmacovigilance agreements (PVAs) and compliance
- Perform CAPA management and deviation tracking
- Oversee distributor/local partner PV compliance
- Support PV audits and regulatory inspections
- Collaborate with cross-functional teams for global safety activities
๐ฏ Required Qualifications & Skills
- Education: Life Sciences degree / Nursing qualification
- Experience: 1โ2 years in pharmacovigilance, drug safety, or medical information
- Strong understanding of:
- ICH Guidelines
- CIOMS safety reporting
- Global PV regulations
- Hands-on exposure to:
- ICSR case processing
- Aggregate safety reports
- PV documentation & compliance
- Excellent English communication (C2 level proficiency preferred)
- Strong analytical, problem-solving, and data management skills
๐ผ Preferred Competencies
- Experience with PV systems & databases
- Understanding of signal detection and risk communication
- Ability to manage multiple safety activities under tight timelines
- Exposure to global pharmacovigilance operations
๐ Why Join Bristol Myers Squibb?
- Work with a top global biopharma leader
- Exposure to international patient safety operations
- Career growth in drug safety, PV strategy, and regulatory compliance
- Flexible and inclusive work environment
- Opportunity to contribute to life-changing therapies
๐ Job Location
- Hyderabad, Telangana, India
- Hybrid / Site-based (as per role requirement)
๐ฐ Salary Insight (India Market Estimate)
- โน8 LPA โ โน12 LPA (based on experience in PV and safety operations)
๐ฉ How to Apply
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