If you’re an experienced Pharmacovigilance (PV) professional looking to advance your career with one of the world’s leading biopharmaceutical companies, Bristol Myers Squibb (BMS) is hiring a Senior Manager, Patient Safety Scientist in Hyderabad, India.
This is an excellent opportunity for professionals with 4โ6 years of pharmacovigilance, drug safety, patient safety science, signal management, aggregate reporting, and risk management experience to contribute to global drug safety programs while working with cross-functional international teams.
Whether your expertise includes Signal Detection, PBRER, DSUR, Risk Management Plans (RMP), Benefit-Risk Assessment, Safety Surveillance, or Regulatory Safety, this opportunity offers outstanding career growth in global pharmacovigilance.
Job Overview
- Position: Senior Manager, Patient Safety Scientist
- Company: Bristol Myers Squibb (BMS)
- Location: Hyderabad, Telangana, India
- Department: Patient Safety
- Employment Type: Full-Time
- Experience Required: 4โ6 Years
- Job ID: R1605042
Key Responsibilities
The selected candidate will support global pharmacovigilance and patient safety activities throughout the product lifecycle.
Signal Detection & Safety Surveillance
- Perform signal detection and signal evaluation activities.
- Review safety literature and quantitative safety data.
- Conduct case-series assessments.
- Lead Safety Data Review Meetings (SDRM).
- Identify and escalate emerging safety concerns.
- Prepare comprehensive signal assessment reports.
- Manage signals using global signal management systems.
Aggregate Safety Reporting
Prepare and review:
- Development Safety Update Reports (DSUR)
- Periodic Benefit-Risk Evaluation Reports (PBRER)
- Periodic Adverse Drug Experience Reports (PADER)
- Safety responses to Health Authorities
- Benefit-risk assessment documentation
Clinical Development Support
Support safety sections for:
- Clinical Trial Protocols
- Clinical Study Reports (CSR)
- Investigator Brochures (IB)
- Reference Safety Information (RSI)
- Informed Consent Forms (ICF)
Participate in:
- Internal safety meetings
- Scientific advice meetings
- Advisory committees
- Data Monitoring Committees
Regulatory Submission Support
Contribute to:
- Marketing Authorization Applications (MAA)
- Integrated Summary of Safety (ISS)
- Summary of Clinical Safety (SCS)
- Clinical Overview documents
- Product labeling updates
- Safety briefing documents
Risk Management
Develop and maintain:
- Global Risk Management Plans (RMP)
- EU Risk Management Plans
- Additional Risk Minimization Measures (aRMM)
- Additional Pharmacovigilance Activities (aPVA)
Coordinate:
- Pregnancy Prevention Programs
- Controlled Distribution Programs
- Educational risk minimization materials
Compliance & Innovation
- Support regulatory inspections and audits.
- Improve PV processes using AI and automation tools.
- Participate in digital transformation initiatives.
- Ensure compliance with global regulatory requirements.
Required Qualifications
Applicants should possess one of the following:
- B.Pharm
- M.Pharm
- PharmD
- B.Sc
- M.Sc
- RN
- MD
- PhD
- Or an equivalent scientific qualification with relevant industry experience
Experience Required
- 4โ6 years of Pharmacovigilance experience
- Drug Safety
- Patient Safety
- Pharmaceutical Industry
- Clinical Development
- Regulatory Safety
Preferred Skills
Candidates with experience in the following areas will be preferred:
- Signal Detection & Management
- Aggregate Report Writing
- PBRER
- DSUR
- PADER
- Benefit-Risk Assessment
- Safety Surveillance
- Risk Management Plans (RMP)
- Pharmacovigilance Regulations
- Global Health Authority Requirements
- Clinical Trial Safety
- Medical Review
- Scientific Literature Review
- Basic Statistics
- AI & Automation in Pharmacovigilance
- Cross-functional Collaboration
- Safety Labeling
- Health Authority Responses
Why Join Bristol Myers Squibb?
Bristol Myers Squibb is recognized globally for developing innovative therapies across oncology, immunology, cardiovascular diseases, hematology, and cell therapy.
Employees benefit from:
- Global career opportunities
- International project exposure
- Competitive compensation
- Hybrid work opportunities (role dependent)
- Learning & development programs
- Inclusive work culture
- Employee wellbeing initiatives
- Career advancement in global pharmacovigilance
Salary (Estimated)
Based on similar Senior Manager Pharmacovigilance roles in India:
Estimated CTC: โน28 LPA โ โน42 LPA
Actual compensation depends on experience, qualifications, and internal compensation policies.
How to Apply
