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xEVMPD / IDMP Specialist
Ref No.: 18-18602
Location: Pennington, New Jersey
Job Description:
• Able to extract the strategic impact of a detailed finding. Work and think at the strategic level, keeping the overall big picture in mind while addressing the details.
• Proactively identify and address complex issues/opportunities. Recommend and implement solutions or bring to appropriate parties for resolution in order to prevent issues from arising or reoccurring.
• xEVMPD Maintenance Coordination:
o Monitor Regulatory Information Management (RIM) system for submission approvals that require xEVMPD reporting.
o Collect, analyze, and quality check data for inclusion in xEVMPD submissions.
o Maintain applicable company Controlled Vocabularies.
o Assess and respond to EMA queries; correspond with EMA helpdesk.
o Oversee communications concerning MedDRA coding.
o Communicate with countries requesting additional information and, when applicable, with executive stakeholders.
o Communicate needs, establish strategy, and resolve issues with EVMPD solution Vendor
o Interact with pharmacovigilance, CMC, and country managers to clarify any questions related to collected data.
o Communicate data issues to team members for resolution.
o Assist in review, approval, implementation, and maintenance of work instructions and procedural documents. Review existing practices and propose updates based on changing regulations and trends.
• IDMP / ISO SPOR intiative contributor:
o Participate in data evaluation and remediation efforts.
o Utililze ISO Standards and Implementation Guides to understand and apply knowledge of the current data environment as well as future proposed data state.

Experience and Educational Requirements
  • A BS in a relevant scientific or technical field and 4-8 years of pharmaceutical industry experience.
  • Experienced 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 a plus.
  • Possesses an in-depth expertise in standard desktop applications and RIM systems, including effective troubleshooting skills. Easily adapts to new software and procedures.
  • Strong attention to detail is essential.
  • Demonstrated ability to follow specific and stringent standards and processes, and to be able to identify when others do not.
  • Excellent command of English language, both written and oral. Strong presentation skills.