Job Title: Senior Manager – Patient Safety Scientist
Location: Hyderabad, Telangana, India
Job Type: Full-Time
Company Overview:
Bristol Myers Squibb (BMS) is a global biopharmaceutical leader dedicated to transforming patients’ lives through science. At BMS, employees engage in meaningful work that spans clinical development, patient safety, and cutting-edge therapeutic innovations. We foster a culture of collaboration, inclusion, and scientific excellence, providing opportunities for professional growth while advancing healthcare globally.
Role Overview:
BMS is seeking a Senior Manager, Patient Safety Scientist to lead pharmacovigilance and patient safety activities across clinical development and post-marketing phases. This role ensures robust signal detection, risk management, and compliance with global safety regulations, supporting the company’s commitment to delivering safe and effective therapies worldwide.
Key Responsibilities:
Signal Detection & Safety Surveillance:
Conduct core signal detection, assessment, and management throughout the product lifecycle.
Utilize safety databases, literature, and quantitative tools to identify, evaluate, and track safety signals.
Author comprehensive signal reports and escalate critical safety issues to the Safety Management Team (SMT).
Contribute to aggregate safety reports, including DSUR, PBRER, and PADER, and respond to ad hoc regulatory safety requests.
Clinical Development Product Support:
Review and contribute to safety sections of clinical documents, including protocols, CSRs, Investigator Brochures, ICFs, and RSI.
Support safety strategy during internal and external meetings, including advisory committees, scientific advice, and pre-submission discussions.
Provide safety expertise for early development programs, including product labeling support and trial oversight.
Regulatory Submission & Postmarketing Safety:
Implement safety strategies for regulatory filings, including MAA submissions, safety tables, ISS, SCS, and labeling updates.
Collaborate with EU QPPV or local QPs on global and local safety requirements.
Ensure risk management plans and additional risk minimization measures are maintained and aligned with regulatory and company standards.
Risk Management Planning & Execution:
Develop and maintain global and local Risk Management Plans (RMPs) and additional Pharmacovigilance Activities (aPVAs).
Coordinate with local markets, vendors, and cross-functional teams for complex risk minimization programs (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs).
Utilize automation and AI tools to enhance safety surveillance, streamline workflows, and improve data analysis.
Cross-Functional Collaboration & Innovation:
Build strong partnerships with SMT, clinical, regulatory, and other stakeholders.
Identify opportunities for process improvement, standardization, and digital transformation in patient safety activities.
Support preparation for audits, inspections, and regulatory compliance initiatives.
Qualifications & Experience Required:
Education: BS, MS, RN, PharmD, PhD, MD, or equivalent with relevant professional experience.
Experience: Minimum 4–6 years in pharmacovigilance, patient safety, clinical development, or pharmaceutical industry roles.
Strong understanding of medical and safety concepts across clinical and postmarketing settings.
Knowledge of global safety regulations, ICH-GCP guidelines, and pharmacovigilance requirements.
Excellent analytical, scientific, and conceptual skills, with attention to detail.
Ability to manage timelines, cross-functional priorities, and complex projects.
Familiarity with AI, digital platforms, and automation tools in safety data management is desirable.
Why Join BMS:
Engage in life-changing work that impacts patients globally.
Collaborate with high-performing teams across patient safety, clinical, regulatory, and medical functions.
Drive innovation in pharmacovigilance through AI, automation, and global safety standards.
Access professional growth opportunities, learning programs, and leadership development.
Equal Opportunity & Accessibility:
BMS is committed to inclusion, diversity, and accessibility. We provide reasonable accommodations for candidates with disabilities and ensure equal employment opportunities for all qualified applicants.
Application Process:
Submit your resume online via the BMS careers portal. BMS will never request payments, financial information, or social security numbers during recruitment.
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