PV Compliance Specialist

4 days ago


Hyderabad, Telangana, India Bristol Myers Squibb Full time
Job Summary

We are seeking a highly skilled PV Compliance Specialist to join our team at Bristol Myers Squibb. This individual will be responsible for ensuring compliance with global regulatory requirements and ensuring the quality and safety of our medicines.

Key Responsibilities
  • Provide compliance 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.
  • Contribute to the development of efficient and effective compliance monitoring programs and processes as well as the PV compliance tools and dashboards that support compliance programs.
  • Collaborate with local and global compliance and quality leads for continuous compliance improvement by ongoing communications regarding any quality trends and reinforcement of process.
  • Contribute to WWPS inspections and audits both proactively in terms of readiness preparation and post-evaluation ensuring implementation of corrective and preventative actions within areas of expertise.
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.
Competencies
  • Operational Skills: Technical Proficiency, Problem-Solving, Process Management
  • Analytical Skills: Data Analysis, Critical Thinking, Data Management
  • Strategic Skills: Strategic Thinking, Decision-Making, Change Management


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