Senior Specialist, Medicinal Product Data Management
Job Summary
Performs EVMPD maintenance coordination through data collection, data entry and data QC for EVMPD and DMP. Maintains understanding of the assigned EVMPD Processes and IDMP business processes. Manages daily workload and independently addresses questions for assigned regulatory processes. Contributes to enhancements in developed areas of expertise. Provides support for internal audits, HA inspections and corrective action plans. Supports management in developed areas of expertise. Recognizes and reports data compliance issues and how they impact assigned processes. Execute operational aspects of enabled processes according to BMS procedures. Create, update and/or execute recent reports in RIM system for any new data entries or updates to existing product data. Collaborate with stakeholders and SMEs to find solutions and rectify any ongoing or potential issues, as needed. Develop working knowledge of global regulatory practices and requirements as they pertain to IDMP and EVMPD. Recognizes and reports data compliance issues,
and able to derive how they impact assigned processes and other processes.
Qualifications
- BA/BS degree, science / technology field preferred.
- 3-5 years of pharmaceutical experience, relevant experience preferred.
- More than 3 years of experience in the management of the Regulatory information of Medicinal products/Vaccines which include performing the data entry and submission through Veeva vault and EV web.
- Solid regulatory knowledge and previous experience in the Regulatory Information Management area
- Clear knowledge and experience with EVMPD, IDMP, and/or SPOR. Possesses knowledge in standard desktop applications and RIM systems, including effective troubleshooting skills.
- Easily adapts to new software and procedures. Strong attention to detail.
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