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    Director, Medical Safety Assessment Physician, Immunology

    Bristol Myers Squibb
    3+ years
    Not Disclosed
    Hyderabad
    10 Aug. 14, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description

    Working with Us

    At Bristol Myers Squibb (BMS), challenging, meaningful, and life-changing work is our everyday reality. Whether optimizing a production line or pioneering breakthroughs in cell therapy, our mission is to transform patients' lives through science. Join us to grow and thrive alongside diverse, high-achieving teams. Discover more about our competitive benefits, services, and programs at careers.bms.com/working-with-us.

    Functional Area Description

    The Worldwide Patient Safety (WWPS) group ensures the safety of our medicines. Our pharmacovigilance and pharmacoepidemiology efforts include single case and aggregate safety monitoring, safety reporting, benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments, and ensuring compliance with global regulatory requirements.

    Position: Safety Lead, Immunology Therapeutic Area

    Position Summary

    As the Safety Lead for assigned compounds/programs in the Immunology Therapeutic Area (TA), you will:

    • Chair the product Safety Management Team(s).
    • Oversee, prepare, and review aggregate safety documents and safety sections of clinical trial documents and regulatory filings.
    • Lead the evaluation and management of safety signals from various data sources.
    • Develop strategies for signal evaluation and document outcomes.
    • Lead safety labeling activities and act as the Safety Subject Matter Expert for regulatory product labeling.
    • Participate in cross-functional labeling team meetings and provide regional safety labeling support.
    • Drive process improvement projects and maintain state-of-the-art Pharmacovigilance (PV) processes.
    • Support the EU Qualified Person for PV or other regional/local Qualified Persons relative to product-related issues.
    • Contribute to Drug Development publication strategies and ensure safety input.
    • Represent WWPS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.

    Key Responsibilities

    1. General Product Support

      • Lead safety activities and benefit-risk strategies.
      • Oversee and review aggregate safety documents (e.g., DSUR, PBRER) and clinical trial documents (e.g., protocols, CSRs, IBs).
      • Manage safety signals and document evaluations.
      • Lead safety labeling initiatives and provide expert input.
      • Support Qualified Persons for PV on product-related issues.
      • Contribute to publication strategies with safety insights.

    2. Clinical Development

      • Serve as the global safety lead for compounds in development.
      • Provide safety input for global submissions and clinical development plans.
      • Develop and execute benefit-risk management strategies.
      • Review and provide input on study protocols, amendments, statistical analysis plans, and regulatory queries.
      • Lead safety-focused publication development.

    3. Post-Marketing Support

      • Act as the safety lead for marketed compounds.
      • Support global post-marketing safety activities and submissions.
      • Oversee risk management strategies and safety signal evaluations.
      • Ensure safety labeling reflects emerging post-marketing data.
      • Guide epidemiology and medical affairs on safety studies.

    4. Department Activities

      • Lead process improvement projects within WWPS.
      • Prepare for regulatory inspections and ensure compliance.
      • Manage issue and crisis management scenarios.
      • Support team hiring, orientation, and foster a collaborative environment.

    5. Cross-Functional Activities

      • Provide strategic input for product safety differentiation.
      • Train BMS employees on product safety profiles.
      • Liaise with various BMS functions (Legal, Business Development, Operations, Marketing).
      • Support manufacturing quality and develop safety communications.

    Qualifications

    • Education: MD or equivalent required; postgraduate qualification in internal medicine, immunology, or related specialty is desirable.

    • Experience:

      • Minimum of 3 years in Pharmacovigilance or related pharmaceutical/biomedical fields (e.g., Medical, Clinical, Regulatory). Clinical research, observational research, or clinical practice experience is also considered.

    • Key Competencies:

      • Deep understanding of the drug development process.
      • Knowledge of Pharmacovigilance and regulatory requirements.
      • Proficient in leveraging tools for safety concern investigations.
      • Strong analytical reasoning and attention to detail.
      • Ability to manage multiple projects concurrently.
      • Excellent verbal and written communication skills.
      • Ability to lead within a complex matrix environment.

    Why You Should Apply

    At BMS, we are passionate about making a meaningful impact on patients with serious diseases. Our inclusive culture empowers you to apply your talents and unique perspectives. Our shared values—passion, innovation, urgency, accountability, inclusion, and integrity—drive us to excel. If a role intrigues you but doesn't perfectly align with your resume, we encourage you to apply anyway. You might be just one step away from a transformative career.

    On-site Protocol

    BMS offers diverse occupancy structures:

    • Site-Essential Roles: Require 100% onsite presence.
    • Site-by-Design Roles: Eligible for a hybrid model with at least 50% onsite.
    • Field-Based and Remote-by-Design Roles: May require travel for meetings and engagements.

    Your occupancy type is determined by your role's nature and responsibilities.

    Equal Employment Opportunity

    BMS is committed to ensuring that individuals with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support. To request accommodations, contact adastaffingsupport@bms.com. For our complete Equal Employment Opportunity statement, visit careers.bms.com/eeo-accessibility.

    Health & Safety

    BMS prioritizes the well-being of our staff, customers, patients, and communities. We strongly recommend that all employees be fully vaccinated for COVID-19 and stay updated with boosters.

    Legal Considerations

    BMS will consider qualified applicants with arrest and conviction records in accordance with applicable laws. Any data processed during role applications will adhere to data privacy policies and regulations.

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