Location: Hyderabad, India
At Bristol Myers Squibb (BMS), we are committed to transformative work that impacts patients' lives worldwide. Our diverse teams drive innovation and uphold the highest standards in pharmaceuticals, ensuring compliance with global regulatory requirements while fostering a culture of growth and diversity.
The Worldwide Patient Safety (WWPS) group oversees pharmacovigilance and pharmaco-epidemiology deliverables, ensuring the safety and efficacy of our medicines through rigorous monitoring, reporting, and compliance with global regulations.
As the PV Operations Administrative Site Lead in Hyderabad, you will provide administrative leadership for the PV Operations & Systems Group, supporting medical review, case management, and systems teams. You will ensure quality excellence and compliance with safety guidelines, managing up to 40 staff members.
Administrative Leadership: Serve as the primary contact for all local administrative matters related to PV Operations in Hyderabad, handling HR issues and general operational oversight.
Quality Monitoring: Lead quality monitoring of Individual Case Safety Reports (ICSRs) processed by vendors, ensuring medical accuracy and compliance with regulatory standards.
Training and Development: Conduct training sessions for the Medical Review group, ensuring continuous improvement in processes and adherence to WWPS standards.
Data Analysis: Analyze trends and data quality metrics, preparing reports and insights for management and stakeholders to facilitate informed decision-making.
Vendor Oversight: Collaborate with PV Compliance and Vendor Quality Monitor to assess vendor performance against contractual obligations and regulatory requirements.
Continuous Improvement: Identify opportunities for process optimization and implement solutions to enhance efficiency and compliance.
Regulatory Compliance: Ensure adherence to ICH Guidelines, MedDRA, and WHO Drug Dictionary usage in medical assessment and reporting processes.
Education: MBBS/MD or Equivalent. Board certification preferred.
Experience: Minimum of 2 years in medical clinical practice and 5 years in corporate pharmaceutical industry, with focus on medical evaluation and adverse event reporting. Quality monitoring experience preferred.
Skills: Proficiency in differential diagnosis, medical writing, SQL, and data analysis. Experience with global safety databases, preferably ArisG.
If you are a passionate leader with a background in medical sciences and pharmaceutical industry, experienced in quality monitoring and regulatory compliance, we encourage you to apply. Join Bristol Myers Squibb in Hyderabad and contribute to our mission of transforming patients' lives through science.
For more details, visit BMS Careers.
This structured format aligns the job description clearly with responsibilities, requirements, and company culture, tailored for potential candidates interested in joining Bristol Myers Squibb in Hyderabad.
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