Manager Dictionary Coding
Manager Dictionary Coding
Global Pharmacovigilance and Epidemiology (GPV&E)
Purpose/Objective of the job
Supports the GPV&E Vision through understanding the impact and implication of daily work on all customers of AE Processing specifically the MedDRA encoded event data from clinical trials.
Establishes and maintains communications between GPV&E and clinical to ensure MedDRA mapping consistency in AWARE and TMS. Participates in an ongoing assessment of AWARE MedDRA encoding TMS interface issues with MedDRA governance bodies. Serves as the GPVE MedDRA point of contact forAWARE vendor. Participates in process and methodology development to insure AWARE MedDRA and WHO drug dictionary processes are current and streamlined.
As requested from regulatory, manages the review/edits/QC and delivery of EVMPD documents containing correct MedDRA codes and decodes for each requested EVMPD activity.
Manage, monitor and respond to requests on the AWARE hub for clinical users requesting AWARE data and Medical information requests understanding the impact of timely, correct outputs delivered to our clinical BMS customers ensuring processes are current and streamlined. Maintains working familiarity with AWARE data base and AWARE data mart (OBIEE).
Directs and organizes work load in order to prioritize deliverables, while maintaining a focus on regulatory compliance implications of global encoded AE data/reporting. Has an understanding of safety regulations both domestic and internationally.
Works both independently, with cross-functional teams, in a matrix environment, while operating within departmental standards while acquiring new skills rapidly on the job. Familiarity with computer system, other IT tools available as an SME. This commitment drives dedication to quality and accuracy contributing to a high performance team.
Key Responsibilities and Major Duties
• Understands the AWARE application's, MEdDRA and WHO drug dictionaries and reference tables. Acts as the cross divisional GPVE MedDRA SME responsible for alignment with and member of the governance bodies for MedDRA at BMS cross divisional CRG and MMC including twice yearly MedDRA /WHO drug up-versioning and related standards in support of Electronic Submission, expedited, aggregate and single case reporting.
• Works closely with AWARE users who identify issues in MedDRA or WHO drug dictionaries.
When MedDRA dictionary upversions, acts as BMS GPVE contact for requesting implementing and participating in MedDRA MSSO upversions as well as ongoing review of clinical synonym mappings/remappings per CRG/MMC between AWARE clinical trial event data and the programmatic interface with MEG TMS database.
• Subject matter expert MedDRA dictionaries.
• Maintain communication channels between GPV&E and clinical for proper processing of MedDRA issues facilitating regulatory compliance globally.
• Manages AWARE hub request site for clinical requests to access blinded AWARE data
Up-to-date about progress on issue resolutions. Learns and understands user's organization and operation. Monitors and works with users regularly to determine opportunities to improve user satisfaction. Thinks and communicates in a clear, decisive manner, remains calm under adverse conditions and reaches independent, reasoned solutions on complex issues.
(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)
GPVE AEP/Coding Associate
Key Stakeholders/Contacts - describe this position's key internal matrix relationships and key external stakeholders/clients
Internal customers include AEPBusiness, Safety Review, Medical review, MEG, Clinical,
External customers include Regulatory (EVMPD)
List of minimum requirements
• Degree/Certification/Licensure Nursing or Medical clinical background with previous work experience in a pharmaceutical company or other laboratory/scientific environment.
• Experience - Responsibility and minimum number of years Nursing or Medical clinical background with previous work experience in a pharmaceutical company or other laboratory/scientific environment.
• Familiarity with Clinical data systems, preferably Adverse Event data systems.
• Two years of experience in Pharmacovigilance combined with a minimum of two years experience in nursing/ clinical medicine.
• Experience working in an intricate drug safety database.
• Experience working in a team environment.
• Demonstrated ability to balance multiple changing priorities in a highly dynamic environment with a demonstrated ability to diagnose and resolve problems and issues.
• Competencies - knowledge, skills, abilities, other Computer literacy and demonstrated ability to learn new software applications.
• Familiarity with computer validation developing a broader understanding of the application development life-cycle and computer validation steps.
• Gain experience in the day-to-day administration of a mission-critical system available 24-7 worldwide
• Understanding of domestic and international drug safety regulations, FDA and ICH
• Pharmacovigilance regulations and usage of Information technology to meet the department's needs.
Software that must be used independently and without assistance (e.g., Microsoft Suite)
Microsoft Suite, AWARE, OBIEE or equivalent safety system
• Travel Required (nature and frequency)
• Overnight Absences Required (per typical month)
• Describe exposure to any hazards/disagreeable conditions in the work environment