Associate Director – Patient Safety Scientist
Location: Hyderabad, Telangana, India
Category: Pharmacovigilance / Drug Safety
Job Type: Full-Time
Overview
Bristol Myers Squibb (BMS) is seeking an experienced Associate Director, Patient Safety Scientist to support global patient safety, signal detection, regulatory strategy, and risk management activities across the product lifecycle. This role provides an opportunity to work on impactful scientific programs that directly contribute to patient safety worldwide.
Key Responsibilities
Signal Detection, Management & Safety Surveillance
Lead core signal detection, signal evaluation, and safety surveillance activities across assigned products.
Review safety literature, clinical data, and quantitative signal detection outputs using various global data sources.
Author high-quality signal assessment reports and ensure timely documentation within safety systems.
Provide medical writing support for safety sections of aggregate reports such as DSURs, PBRERs, and PADERs.
Mentor junior safety scientists in signal evaluation and regulatory response preparation.
Clinical Development Safety Support
Lead safety input for protocols, clinical study reports (CSR), Investigator’s Brochures (IB), reference safety information (RSI), and informed consent forms (ICF).
Represent Patient Safety in internal and external scientific meetings, advisory committees, and submissions.
Regulatory Submissions & Post-Marketing Safety
Contribute to safety strategy for global regulatory filings (MAA, NDA, BLA).
Prepare and review Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), safety labeling, briefing books, and responses to Health Authority queries.
Support global and local safety teams with emerging post-marketing safety data and labeling updates.
Risk Management
Lead development and updates of global and EU Risk Management Plans (RMPs).
Oversee additional Risk Minimization Measures (aRMMs) and Pharmacovigilance Activities (aPVAs).
Collaborate with epidemiology teams on risk minimization effectiveness and post-authorization safety studies (PASS).
Departmental & Cross-Functional Excellence
Drive digital innovation and automation opportunities within safety science workflows.
Support inspection readiness, audit preparation, and alignment with global safety regulations.
Lead cross-functional initiatives, process improvements, and matrix teams to support safety strategy and regulatory deliverables.
Qualifications & Experience Required
Scientific Degree: BS, MS, RN, PharmD, PhD, MD, or equivalent scientific/clinical qualification.
Experience:
Minimum 6–8 years in pharmacovigilance, drug safety, or pharmaceutical/biotech industry.
Strong expertise in safety surveillance, clinical development, regulatory submissions, and risk management.
Ability to synthesize complex clinical data, interpret medical concepts, and support strategic safety decisions.
Demonstrated capability in scientific writing, stakeholder communication, and project leadership.
Proficiency in safety data analysis, foundational statistics, and familiarity with digital/AI-enabled tools.
Work Model
Based on BMS’s on-site protocol, this role follows the designated occupancy structure for site-by-design positions, requiring on-site presence as per business needs.
Why Join BMS?
Work on high-impact scientific programs that transform patient lives.
Be part of a global, collaborative, innovation-driven organization.
Access competitive benefits, flexible work models, and diverse development opportunities.
Application Deadline
Apply as soon as possible if your experience aligns, even if you do not meet every requirement.
Gujarat :
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Siliguri |Illinois :
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