Senior Manager – Patient Safety Scientist
Location: Hyderabad, Telangana, India
Category: Pharmacovigilance | Drug Safety
Job Type: Full-Time | On-site/Hybrid (as per company policy)
Job Overview
Bristol Myers Squibb (BMS) is seeking a highly skilled Senior Manager, Patient Safety Scientist to support global safety surveillance, signal detection, regulatory submissions, and risk management across the full product lifecycle. This role is ideal for experienced pharmacovigilance professionals looking to contribute to impactful, science-driven safety programs.
Key Responsibilities
Signal Detection, Management & Safety Surveillance
Perform and oversee signal detection, literature review, and quantitative signal identification.
Lead safety data review meetings (SDRMs) and escalate critical issues to the Safety Management Team (SMT).
Conduct signal evaluation activities including case series, literature review, and database analysis.
Author comprehensive signal assessment reports and ensure timely documentation in safety systems.
Prepare safety content for aggregate reports such as DSURs, PBRERs, and PADERs.
Support global and local teams with ad hoc safety responses to Health Authorities.
Clinical Development Safety Support
Contribute to safety sections of clinical documents such as:
Protocols
Investigator Brochures (IB)
Clinical Study Reports (CSR)
Reference Safety Information (RSI)
Informed Consent Forms (ICF)
Represent Patient Safety at internal and external scientific and regulatory meetings.
Regulatory Submissions & Post-Marketing Support
Contribute to global safety strategy for regulatory submissions, including MAA/NDA/BLA filings.
Prepare and review safety sections of ISS, SCS, labeling documents (USPI, CCDS, SmPC), and briefing materials.
Support labeling updates and evaluate emerging post-marketing safety data.
Assist EU QPPV and regional safety leads with safety activities related to assigned products.
Risk Management Planning & Execution
Develop and update EDSR and Risk Management Plans (RMPs) for global and EU markets.
Lead additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs).
Collaborate with epidemiology teams on PASS and risk minimization assessments.
Coordinate with affiliates and vendors on delivery of complex and non-complex risk minimization tools.
Departmental Operations & Cross-Functional Collaboration
Integrate digital innovation, automation tools, and AI-generated outputs to enhance safety workflows.
Support regulatory inspections and audits to ensure compliance with global safety standards.
Participate in cross-functional process improvement initiatives and contribute to SOP updates.
Strengthen partnerships with clinical, regulatory, medical affairs, and epidemiology teams.
Qualifications & Experience Required
Scientific Degree: BS, MS, RN, PharmD, PhD, MD, or equivalent scientific qualification.
Experience:
Minimum 4–6 years in pharmacovigilance, drug safety, or pharmaceutical industry.
Strong understanding of medical concepts, clinical development safety activities, and global regulatory safety requirements.
Skilled in data review, analytical assessment, scientific interpretation, and safety documentation.
Experience with aggregate reports, signal detection methodologies, and risk management planning.
Demonstrated ability to manage timelines, collaborate cross-functionally, and maintain high-quality deliverables.
Familiarity with statistical concepts and emerging automation/AI tools for safety data analysis.
Work Model
This role follows BMS’s site-by-design or hybrid structure based on business needs, requiring on-site presence for collaboration, productivity, and innovation.
Why Join BMS?
Work on impactful scientific programs that contribute to global patient safety.
Grow your career in an innovation-driven, diverse, and collaborative organization.
Access competitive benefits and professional development opportunities.
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