Senior Specialist, Medicinal Product Data Management

3 weeks ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time

Job Summary

The Sr. Specialist, Medicinal Product Data Management supports the EVMPD and IDMP Operations Group, collecting EVMPD and IDMP data, performing data entry, QC, and data maintenance to maintain compliance with current EVMPD regulations and upcoming global regulatory requirements.

Key Responsibilities

  • Demonstrates knowledge and experience with EVMPD, IDMP, and SPOR.
  • Performs EVMPD maintenance coordination through data collection, data entry, and data QC.
  • Maintains understanding of assigned EVMPD processes and IDMP business processes.
  • Manages daily workload and addresses questions for assigned regulatory processes with minimal guidance.
  • Contributes to enhancements in developed areas of expertise.
  • Recognizes and reports data compliance issues and derives their impact on assigned processes and other processes.
  • Creates, updates, and executes new reports in RIMS for new data entries or updates to existing product data for IDMP with strong attention to detail.
  • Gathers documentation and participates in dossier reviews required for IDMP data collection and RIMS data entry to support Global Product Supply.
  • Reviews and analyzes the mapping of BMS List of Values to SPOR and submits requests for new required terms when applicable.
  • Collaborates with stakeholders and SMEs to find solutions and rectify ongoing or potential issues.
  • Develops working knowledge of global regulatory practices and requirements as they pertain to IDMP and xEVMPD.
  • Demonstrates ability to follow specific standards and processes and identifies when others do not.

Requirements

  • BA/BS degree, science/technology field preferred.
  • 3-5 years of pharmaceutical experience, relevant experience preferred.

Competencies

  • Foundational knowledge of global regulatory practices, submission guidelines, and requirements.
  • Assists in implementing short- and long-term goals within own work group within RISM.
  • Comes prepared with solutions to questions and issues as they arise.
  • Engages relevant stakeholders to help address problems.
  • Proficient in the English language, both written and oral, and able to communicate effectively in written form with non-English speakers.
  • Demonstrates basic presentation skills needed to deliver content to a variety of audiences.
  • Demonstrates ability to execute a non-complex project, including prioritizing tasks with strong attention to detail.
  • Communicates project status and updates, as appropriate, to relevant stakeholders.

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