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Job Title: xEVMPD / IDMP Specialist
Location: Hopewell, NJ
Duration: 6 Months
Department Title and Description
Global Regulatory Business Capabilities (GBRC)
Global Submissions and Regulatory Policy (GSRP)
Purpose/Objective of the job
Provide data gathering, data entry and data QC support for the xEVMPD (Extended EudraVigilance Medicinal Product Dictionary) Operations Group in compliance with EMA's Article 57(2) Regulation. Provide tactical and strategic support for the IDMP / ISO SPOR program by providing subject matter expertise and performing data evaluation and remediation activities.
Key Responsibilities and Major Duties
· 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 Client 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.
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship) N/A. Associates in this position are individual contributors.
· Establish and execute plans for managing workload within assigned project(s) through efficient resource utilization and within designated timeframes. Effectively adjust plans to deal with changes and obstacles.
· Collaborate across cultural and organization boundaries to achieve business results.
· Refined attention to detail and critical thinking capabilities. Follow specific and stringent standards and processes.
· Remain calm and think in a clear, decisive manner while under adverse conditions and changing priorities.
· Embrace a healthy work environment with sensitivity to the balance between personal and professional life.
· 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.
Interested candidates can send their updated resumes on email@example.com and you can also reach me at 973-967-3431.
Artech Information Systems LLC.
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