🧬 Director, Medical Safety Assessment Physician
📍 Location: Hyderabad, Telangana, India
🏢 Company: Bristol Myers Squibb (BMS)
🔹 Category: Medical & Safety / Pharmacovigilance
🕒 Employment Type: Full-time
🌍 About Bristol Myers Squibb
At Bristol Myers Squibb (BMS), every day brings work that is challenging, meaningful, and life-changing. Whether it’s advancing cell therapy or developing breakthrough treatments, your contributions will help transform patients’ lives through science™.
BMS values balance, flexibility, and inclusion. Employees enjoy a wide range of competitive benefits, career development opportunities, and resources to achieve both professional and personal goals.
Learn more at careers.bms.com/working-with-us.
🎯 Role Overview
The Director, Medical Safety Assessment (MSA) Physician leads global safety activities, benefit–risk strategies, and pharmacovigilance processes for assigned compounds and products at BMS.
This position chairs Safety Management Teams (SMTs) and provides medical safety leadership throughout the product life cycle — from clinical development through postmarketing.
⚕️ Key Responsibilities
1️⃣ General Product Safety Leadership
Lead safety activities and benefit–risk management strategies for assigned BMS compounds.
Chair Safety Management Teams (SMTs).
Oversee, prepare, and review aggregate safety reports, including DSURs, PBRERs, and sections of clinical trial or regulatory documents (protocols, CSRs, IBs, ICFs, CTAs, MAAs).
Manage evaluation and documentation of emerging safety signals from any data source.
Direct safety labeling activities and ensure regulatory labeling accuracy.
Support EU QPPV or regional PV leads regarding assigned products.
Contribute safety input to R&D publication strategies, ensuring accuracy in scientific communications.
2️⃣ Clinical Development
Serve as Global Safety Lead for compounds in development.
Provide safety input for clinical development plans, protocols, SAPs, IBs, CSRs, and regulatory responses.
Develop and execute benefit–risk management strategies and risk minimization plans.
Review safety sections of integrated submissions and safety summaries.
Support preparation for regulatory and scientific advisory meetings, DMCs, and pre-submission safety reviews.
3️⃣ Postmarketing Safety Oversight
Act as the safety lead for marketed compounds and global postmarketing submissions.
Lead medical safety signal evaluation and management using evidence-based methodologies.
Provide input for aggregate postmarketing safety reports and product renewals.
Oversee risk management plan (RMP) implementation and monitoring.
Collaborate with epidemiology and medical affairs teams on safety studies, including ISRs and non-interventional studies.
Ensure labeling reflects emerging postmarketing safety data.
4️⃣ Departmental and Process Excellence
Lead and support process improvement projects within Global Pharmacovigilance and Medical Safety.
Assist MSA Therapeutic Area (TA) Heads in maintaining state-of-the-art PV systems.
Support regulatory inspection readiness by ensuring process compliance with global guidelines.
Participate in issue management, crisis response, and cross-departmental alignment.
Mentor and guide colleagues to foster teamwork and continuous learning.
5️⃣ Cross-Functional and Strategic Collaboration
Provide strategic input for product safety differentiation and positioning.
Deliver safety training to BMS employees and cross-functional teams.
Liaise with key internal stakeholders (Legal, Operations, Marketing, Manufacturing).
Co-author Health Hazard Assessments and global safety communications.
Represent WWPS (Worldwide Patient Safety) at Health Authority meetings and Data Monitoring Committees.
🎓 Education and Experience
|
Qualification |
Requirement |
|---|---|
|
Degree |
MD or equivalent (Postgraduate qualification preferred) |
|
Specialization |
Internal Medicine, Immunology, Oncology, or related specialty desirable |
|
Experience |
Minimum 3+ years in Pharmacovigilance, Medical Affairs, Clinical, or Regulatory roles |
|
Other Considerations |
Experience in clinical or observational research highly valued |
🧠 Key Skills & Competencies
Deep understanding of drug development and PV lifecycle management.
Expertise in signal detection, risk assessment, and benefit–risk evaluation.
Strong analytical reasoning and scientific communication skills.
Proficiency in observational research tools and data analysis.
Excellent attention to detail, time management, and multitasking ability.
Proven ability to lead within a complex matrix environment.
Outstanding verbal and written communication skills.
🤝 BMS Values and Culture
Mission: Transforming patients’ lives through science™
Core Values: Passion, Innovation, Urgency, Accountability, Inclusion, Integrity
A culture built on teamwork, collaboration, and continuous growth.
🏢 Work Model
BMS follows an occupancy structure based on role requirements:
Site-essential: 100% onsite.
Site-by-design: Hybrid with ≥50% onsite.
Field-based / Remote-by-design: Travel as needed for meetings and business needs.
This role’s occupancy classification will be determined based on responsibilities.
⚖️ Equal Opportunity and Accessibility
BMS is committed to creating an inclusive workplace for all.
Applicants with disabilities can request reasonable accommodations during the hiring process.
Equal opportunity regardless of race, color, religion, gender, national origin, sexual orientation, age, or disability.
Learn more: careers.bms.com/eeo-accessibility
❤️ Additional Information
BMS strongly encourages all employees to stay fully vaccinated against COVID-19.
Employment decisions comply with applicable local laws on arrest and conviction records.
Privacy of applicant data is ensured in accordance with BMS data protection policies.
🚀 Join BMS
At Bristol Myers Squibb, you’ll find uniquely interesting work and life-changing careers.
If you’re passionate about advancing science, improving safety, and making a global impact —
Apply Now to take your career farther than you ever imagined.
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