- GDMS Product Master Data Stewardship for VIPER Program Overview
- Working collaboratively with data stewards from Research, Development and Medical, responsible to ensure the timely review and entry into GDMS of product identifiers (i.e., compound number, generic name and trade name) as requested by VIPER Business Workstream team members
- Responsibilities
- Establish a documented process and service level parameters for cycle time to add product identifiers into GDMS
- Address requests for bulk loading of 100s of product identifiers as well as 1 or 2 at a time
- Work collaboratively with data stewards from the business units to coordinate and manage delivery on requests for addition of product identifiers and resolution of issues
- Work collaboratively with BT-Medical, Business Intelligence and Regulatory Information Management groups in order to define and ensure compliance with standards for product identifiers across Pfizer
- With respect to any request to add product identifiers into GDMS:
- Perform analysis to screen out requests that would lead to duplication of product identifiers in GDMS
- Perform analysis to ensure consistency of product identifiers with those already configured in GDMS
- Perform analysis to ensure synonyms and/or multiple values for compound numbers, generic names and trade names are correctly associated with a single product in GDMS
- Work collaboratively and review requests for addition of compound numbers with data stewards of the RGate application to ensure alignment
- Work collaboratively and review requests for addition of PF-Numbers with data stewards of the GeCR application to ensure alignment for PF-Numbers associated with any product (NOTE: PF-Number may represent a product of any type)
- Work collaboratively and review requests for addition of compound numbers and generic names with data stewards of the Snapshot application to ensure alignment for identifiers of investigational products undergoing clinical studies
- Work collaboratively and review requests for addition of generic names and trade names with data stewards of the PDM and GRPM applications including GRS to ensure alignment for identifiers of investigational and marketed products
- GDMS Required 4-7 Years Advanced Experience
- MS Excel Required 4-7 Years Advanced Experience
- Data Query Required 4-7 Years Intermediate Experience
- Data Validation Required 1-3 Years Base/Entry Experience
- Database Management Required 1-3 Years Base/Entry Experience
- Regulatory Documentation Required 4-7 Years Intermediate Experience
- Demonstrated effectiveness in defining, documenting and ensuring compliance with standard operating procedures
- Demonstrated effectiveness with data review and research using tools such as Microsoft Excel
- Demonstrated effectiveness in project management and delivery on short cycle service requests such as those for addition of product identifiers to GDMS
- Demonstrated effectiveness at defining and tracking service performance metrics
- Demonstrated understanding of drug development lifecycle from discovery through registration, production manufacturing, and commercial marketing
- Demonstrated knowledge of common systems and elements of information architecture used throughout the product development process
- Understanding of record and document types associated with managing product research and development projects through to product registration and market, including products in pharmaceuticals (prescription drug products and compounds), consumer healthcare (over the counter products, including drugs, devices, vitamins, et al) and the nutritional (e.g., baby formula) markets
- Demonstrated effectiveness in working collaboratively and communicating proactively as a member of a team
- BS/BA required with a minimum of five years of experience in Information Management
- Strong understanding of scientific data, databases and document management systems required (EDMS / GDMS)
Please Include Job Title and Location in the Subject Line of Your Email
No comments:
Post a Comment