Associate Director – Patient Safety Scientist
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Experience Required: 6–8+ years in pharmacovigilance, clinical development, or drug safety
About Bristol Myers Squibb (BMS)
Bristol Myers Squibb is a global biopharmaceutical company committed to transforming patients’ lives through science. Our mission is to advance innovative therapies across multiple therapeutic areas while fostering a culture of excellence, inclusion, and collaboration. At BMS, employees are empowered to grow, thrive, and make a meaningful impact on global health outcomes.
Role Overview
BMS is seeking an experienced Associate Director – Patient Safety Scientist to lead and execute patient safety, pharmacovigilance, and risk management activities for assigned products. This role will partner with cross-functional teams, health authorities, and stakeholders to ensure proactive safety surveillance, effective signal detection, and robust risk management across the product life cycle.
Key Responsibilities
Signal Detection & Safety Surveillance
Lead core signal detection, assessment, and management activities throughout the product lifecycle.
Review clinical, nonclinical, post-marketing, and literature data to identify emerging safety concerns.
Develop and author comprehensive signal reports, ensuring timely stakeholder engagement and documentation.
Provide expert medical writing support for aggregate safety documents (DSUR, PBRER, PADER) and regulatory queries.
Clinical Development & Regulatory Support
Lead preparation and review of safety sections in protocols, clinical study reports (CSRs), investigator brochures, informed consent forms, and regulatory documents.
Represent patient safety in internal and external meetings, advisory committees, and pre-submission discussions.
Contribute to safety strategy, risk management approaches, and safety messaging for regulatory filings and labeling updates.
Risk Management Planning & Execution
Develop and maintain global and regional Risk Management Plans (RMPs) and additional Risk Minimization Measures (aRMMs).
Collaborate with epidemiology and local markets to evaluate risk minimization effectiveness and post-authorization safety studies (PASS).
Provide guidance for complex safety programs, including Pregnancy Prevention Programs and Controlled Distribution Programs.
Cross-Functional Leadership & Innovation
Foster collaboration across Safety, Clinical, Regulatory, and Commercial teams to drive alignment and informed decision-making.
Identify and implement process improvements, digital tools, and AI-based solutions to optimize workflows and enhance safety data analysis.
Mentor and guide less experienced scientists, promoting a culture of scientific rigor, accountability, and continuous improvement.
Qualifications & Experience
Scientific or medical degree (BS, MS, RN, PharmD, PhD, MD) or equivalent combination of education and professional experience.
Minimum 6–8 years of relevant experience in pharmacovigilance, patient safety, or drug development, with demonstrated ability to mentor others.
Strong expertise in signal detection, risk management, clinical trial safety, and regulatory submissions.
Proficiency in medical writing, data interpretation, and presentation of complex scientific data.
Knowledge of emerging technologies (AI, automation, digital platforms) to optimize safety processes is a plus.
Excellent communication, organizational, and cross-functional leadership skills.
Why Join BMS
Opportunity to contribute to life-changing therapies and global health impact.
Work in a collaborative, inclusive, and high-performing environment.
Engage with cutting-edge tools, AI-enabled data analysis, and innovative pharmacovigilance strategies.
Competitive benefits and programs to support professional and personal growth.
Equal Opportunity & Accessibility
BMS is committed to providing a workplace free of discrimination, promoting inclusion, and supporting individuals with disabilities through reasonable accommodations. All qualified applicants will receive consideration regardless of race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
SEO & GEO Optimization Highlights:
Keywords: Patient Safety Scientist India, Pharmacovigilance Jobs Hyderabad, BMS Careers India, Clinical Safety Associate Director, Drug Safety Officer Hyderabad.
Location-specific targeting: Hyderabad, Telangana, India.
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