Bristol Myers Squibb (BMS) is a global biopharmaceutical company committed to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a mission to transform patients’ lives through science, BMS fosters a culture of passion, innovation, urgency, accountability, inclusion, and integrity.
At BMS, employees engage in uniquely interesting and life-changing work across various departments—from optimizing production lines to breakthroughs in cell therapy. The company offers competitive benefits, flexible work environments, and unparalleled career growth opportunities.
Job Description
Key Responsibilities:
- Act as the primary point of contact with Health Authorities on safety-related matters.
- Implement and maintain Risk Management Plans (RMPs) and Additional Risk Minimization Materials (aRMMs).
- Handle safety information-related activities and ensure compliance with pharmacovigilance (PV) regulations.
- Identify PV activities and implement Standard Operating Procedures (SOPs).
- Ensure PV Audit and Inspection Readiness and maintain compliance with global PV standards.
- Develop training modules and organize PV-related training sessions.
- Plan, process, and submit Aggregate Reports (PSURs, PBRERs, DSURs) to Health Authorities.
- Establish and maintain a Quality Management System (QMS) for PV operations.
- Manage Pharmacovigilance Agreements (PVAs) with partners and vendors.
- Collect, follow up, and report Adverse Events (AEs) from spontaneous, literature, solicited, and post-marketing sources.
- Submit Individual Case Safety Reports (ICSRs) from clinical trials to local Health Agencies and Ethics Committees.
- Ensure Local Market Safety Data Quality and maintain the Local Pharmacovigilance System Master File (PSMF).
Qualifications & Experience:
- Education: Bachelor’s or Master’s in Pharmacy (B.Pharm, M.Pharm, Pharm.D) or a Medical degree (MBBS, MD).
- Experience: 6-7 years in Regulatory Affairs, Clinical Operations, or Medical Affairs within the pharmaceutical industry, with at least 4 years in Pharmacovigilance (PV).
- Skills: Strong knowledge of global PV regulations (GVP, ICH-GCP), risk management, and safety reporting.
Why Join Bristol Myers Squibb?
- Impactful Work: Contribute to life-changing therapies for patients worldwide.
- Career Growth: Opportunities for professional development in a global biopharma leader.
- Inclusive Culture: A diverse and supportive work environment.
- Flexibility: Hybrid work options (where applicable) and employee wellness programs.
