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Senior Manager, Medical Safety Review

1-2 years
Not Disclosed
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 Title: Senior Manager, Medical Safety Review

Location: Not specified (Note: On-site, hybrid, or remote work arrangements may apply based on role and responsibilities.)

Company Overview: At Bristol Myers Squibb (BMS), we believe in the extraordinary power of our work to make a difference. Our mission extends beyond conventional job roles, encompassing groundbreaking work from optimizing production lines to pioneering cell therapies. We are committed to transforming patients' lives and fostering careers through unique opportunities and a diverse, high-achieving team environment. Discover more about our culture and benefits at careers.bms.com.

Position Summary: As a Senior Manager in Medical Safety Review, you will play a crucial role in ensuring the safety of our medicines through detailed medical review of Individual Case Safety Reports (ICSRs). This role supports signal detection and risk management activities, contributing to the overall safety of our products.

Key Responsibilities:

  • Medical Review: Perform high-quality medical assessments of ICSRs for both clinical trial and post-marketing reports, including serious cases (e.g., SUSARs, AEs of Interest, pDILI, pregnancy-related events). Determine the regulatory reportability and oversee medical reviews conducted by vendors, if applicable.
  • Compliance: Ensure timely and complete reporting of ICSRs to global regulatory authorities. Implement quality controls and collaborate with Quality, Standards, and Training teams to maintain consistency in practices and SOPs.
  • Collaboration: Partner with Worldwide Patient Safety (WWPS) personnel, Clinical Development, and Business Partners to evaluate the safety profile of products. Identify and escalate potential safety signals and critical cases to relevant stakeholders.
  • Development/Processes: Address safety-related issues with strategic medical and regulatory insights, influence consensus, and drive actions to meet regulatory objectives. Represent WWPS effectively and ensure efficient task performance aligned with quality, accuracy, and safety goals.

Education and Experience:

  • Required: MD or equivalent degree; minimum of 2 years in clinical practice or relevant settings; at least 1 year of pharmaceutical industry experience preferred.
  • Preferred: Board certification and medical specialty; experience with safety databases (e.g., ArisG); proven ability to handle safety-related issues, support team collaboration, and manage projects autonomously.

Key Competencies:

  • In-depth knowledge of medicine and pharmaceutical safety.
  • Experience in interpreting individual case reviews and reporting adverse events.
  • Creative problem-solving skills with a focus on continuous improvement.
  • Strong communication, interpersonal, and time management skills.
  • Ability to adapt to a rapidly changing environment and motivate others.
  • Experience with safety databases and tools is a plus.

Work Environment: BMS offers diverse work arrangements, including site-essential, site-by-design, field-based, and remote-by-design roles. The type of work environment will depend on the role's responsibilities. We support employees with disabilities through a transparent recruitment process and reasonable workplace accommodations. We also strongly recommend Covid-19 vaccinations and boosters for all employees.

Application Information: Bristol Myers Squibb is committed to diversity and inclusion and encourages all qualified candidates to apply, regardless of background. We will consider applicants with arrest and conviction records in accordance with applicable laws. For reasonable accommodation requests during the recruitment process, please contact adastaffingsupport@bms.com.

Join us and be part of a team dedicated to transforming patients' lives through science. Apply today to make a meaningful impact and advance your career at Bristol Myers Squibb.