Senior Pharmacovigilance Compliance Specialist

1 month ago


Hyderabad, Telangana, India Bristol Myers Squibb Full time

Job Summary

We are seeking a highly skilled Senior Pharmacovigilance Compliance Specialist to join our team at Bristol Myers Squibb. As a key member of our Worldwide Patient Safety group, you will be responsible for ensuring the safety of our medicines and ensuring compliance with global regulatory requirements.

Key Responsibilities

  • Provide quality oversight through ongoing monitoring of safety outputs created by WWPS to ensure continuous compliance and quality excellence with all applicable safety guidelines and regulations.
  • Ensure ongoing regulatory compliance and mitigation of potential risks associated with PV activities delivered by WWPS.
  • Collaborate with local and global Quality oversight leads, Case Management and Medical Review Teams for continuous quality improvement by ongoing communications regarding any quality trends and reinforcement of process.
  • Perform quality and compliance monitoring activities with respect to safety signals, key medical safety information such as safety information in product labels, Individual Case Safety Reports (ICSRs), and other relevant areas of pharmacovigilance in support of a strong GVP Quality Management System.

Requirements

  • A minimum of 5 years pharmaceutical industry experience, including 3 years of pharmacovigilance, drug development, clinical development or regulatory affairs experience specifically involving Safety Database case processing.
  • Prior experience in IT project management including the skills for JIRA management, HP ALM, and share point management is preferred.
  • Strong scientific background in a life science related field
  • Prior quality related experience in pharmacovigilance preferred.

What We Offer

Bristol Myers Squibb is a diverse and inclusive company that offers a range of benefits and opportunities for growth and development. We are committed to creating a workplace that is welcoming and inclusive for all employees.



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