Specialist / Sr Specialist / Manager- (Medicinal Product Data Management)

Shift Timings: General Shift

Experience - 3- 10 years

Must have skills- xEVMPD, RIMS (Good To have Veeva Vault experience)

Position Summary :-

The role, Medicinal Product Data management supports the EVMPD (Extended EudraVigilance Medicinal Product Dictionary) and IDMP (Identification of Medicinal Products) Operations Group. This role will also support future MPDM health authority data requirements and deliverables.

This role will collect EVMPD and IDMP data, perform data entry, QC, and data maintenance support to maintain compliance with current EVMPD regulations and to meet upcoming global regulatory requirements for submission of IDMP data based on local implementation guides.

• Key Responsibilities: -

• Performs EVMPD maintenance coordination through through data collection, data entry and data QC for EVMPD
• 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
• Executes operational aspects of enabled processes according to BMS procedures.
• Create, update and/or execute new 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.
• Experience with the life cycle of marketed products (preferred, but drug development experience will also be considered) processes.
• Solid regulatory knowledge and previous experience in the Regulatory Information Management area
• Demonstrate experience and understanding of the procedures and decision-making process of Health Authorities as it relates to RIM.
• 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.
• Excellent command of English language, written and oral.
• Demonstrated ability to follow specific standards and processes and ability to identify when others do not.

Qualifications & Experience: -

BA/BS degree, science / technology field preferred