Medical Data Specialist

2 weeks ago


Hyderabad, Telangana, India Bristol Myers Squibb Full time
About the Role

We are seeking a highly skilled Medical Data Specialist to join our team in ensuring global regulatory compliance for medicinal product data management.

As a key member of our organization, you will be responsible for collecting and maintaining EVMPD and IDMP data, performing data entry, quality control, and data maintenance to meet current regulations and upcoming global requirements.

Responsibilities
  • Demonstrate expertise in EVMPD, IDMP, and SPOR, as well as knowledge of global regulatory practices and submission guidelines.
  • Maintain understanding of assigned EVMPD processes and IDMP business processes, including daily workload management and addressing questions with minimal guidance.
  • Contribute to enhancements in developed areas of expertise, recognizing and reporting data compliance issues and their impact on assigned processes.
  • Create, update, and execute new reports in RIMS for new data entries or updates to existing product data for IDMP, with strong attention to detail.
  • Gather documentation and participate in dossier reviews required for IDMP data collection and RIMS data entry to support Global Product Supply (GPS).
  • Review and analyze the mapping of BMS List of Values to SPOR and submit requests for new required terms when applicable.
  • Collaborate with stakeholders and SMEs to find solutions and rectify ongoing or potential issues.
  • Develop working knowledge of global regulatory practices and requirements as they pertain to IDMP and xEVMPD.
Requirements
  • Bachelor's degree in science/technology field preferred.
  • 3-5 years of pharmaceutical experience, relevant experience preferred.
  • Fundamental knowledge of global regulatory practices, submission guidelines, and requirements.
  • Ability to prioritize tasks with strong attention to detail, communicate effectively in written form, and present content to various audiences.
About Us

Bristol Myers Squibb is committed to transforming patients' lives through science. Our company values passion, innovation, urgency, accountability, inclusion, and integrity, fostering an inclusive culture that promotes diversity in clinical trials.

We offer a unique opportunity to work in a dynamic environment, collaborate with talented individuals, and contribute to life-changing careers. If you are a motivated and detail-oriented professional looking to make a difference, we encourage you to apply.



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