Job Title:
Director, Medical Safety Assessment Physician
Location:
Hyderabad, Telangana, India
Position Summary:
Lead safety activities and benefit-risk strategies for assigned compounds and chair the Product Safety Management Team(s).
Oversee and review aggregate safety documents, clinical trial safety sections, and regulatory filings.
Lead evaluation and management of safety signals emerging from various data sources.
Drive safety labeling activities and act as the Safety Subject Matter Expert for regulatory labeling input.
Support process improvement initiatives within Pharmacovigilance (PV) and R&D departments.
Represent Patient Safety (PS) at Health Authority and Data Monitoring Committee meetings.
Mentor peers and promote teamwork within the organization.
Key Responsibilities:
General Product Support:
Prepare, review, and oversee periodic safety reports and clinical trial safety documentation.
Develop strategies for signal evaluation and document safety findings.
Support regulatory product labeling processes and provide safety insights into publications.
Act as safety lead for post-marketing safety activities.
Clinical Development:
Serve as the global safety lead for assigned compounds under development.
Provide strategic safety input into clinical development plans and documents.
Lead the development and execution of benefit-risk management strategies.
Support safety strategy planning for regulatory submissions and advisory meetings.
Post-Marketing Support:
Oversee safety activities for marketed products and global post-marketing submissions.
Lead execution of risk management strategies and risk minimization activities.
Conduct safety signal evaluations and review emerging post-marketing safety information.
Collaborate on post-marketing safety studies and ensure regulatory compliance.
Departmental Activities:
Lead process improvement projects in PV.
Support regulatory inspection readiness and issue management.
Promote collaboration across safety teams and support new hire orientation.
Cross-Functional Activities:
Contribute to strategic plans for safety differentiation.
Provide safety training and act as a liaison across Legal, Business Development, Operations, and Marketing.
Support integrated health hazard assessments for manufacturing quality.
Qualifications:
Education:
MD or equivalent degree required.
Postgraduate specialization in internal medicine, immunology, oncology, or a related field is preferred.
Experience:
Minimum of 3 years in Pharmacovigilance or a related pharmaceutical/biomedical field (Medical, Clinical, Regulatory).
Clinical research and observational research experience will be considered.
Skills and Abilities:
Strong understanding of drug development and pharmacovigilance regulations.
Proficiency in safety data evaluation and risk minimization strategies.
Excellent scientific analytical reasoning and problem-solving abilities.
Ability to manage multiple projects simultaneously with attention to detail.
Strong communication and leadership skills, with ability to work in complex matrix environments.
Ability to utilize real-time data management to influence decision-making.
Travel Requirement:
Not Applicable.
About Bristol Myers Squibb:
At BMS, employees are empowered to make a meaningful impact through challenging and life-changing work. Our values — passion, innovation, urgency, accountability, inclusion, and integrity — drive us to transform patients’ lives through science.
On-Site Work Requirement:
This is a site-by-design role requiring at least 50% onsite presence at the assigned facility.
Equal Opportunity Employer:
BMS is an Equal Employment Opportunity employer. We value diversity and provide reasonable accommodations to applicants with disabilities.
For more information, visit: careers.bms.com
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