ANSHU KUMARI

GSK Copy Approval Process

Operations Management: organization and planning of activities, analysis of productivity and quality of the team's services; responsible for ensuring that SLAs are respected with business and reducing potential bottlenecks to ensure maximum team utilization on new projects initiatives.

Team management: managing a team consisting of 6 FTEs

• Set clear performance goals and KPIs
• Task allocation, performance tracking and leave management.
• Provided regular coaching, training and feedback ensure individual and team performances.
• Quality check on work done by team members.
• Improved team productivity by streamlining workflow processes, sharing best practices, implementing efficient project management practices.
• Developed comprehensive training materials to onboard new team members quickly and efficiently.
• Enhanced client satisfaction with effective communication, regular progress updates, and prompt resolution of concerns.
• Generate monthly Zinc reports for Global Franchises and share the insights using Microsoft Excel and Power BI.
• Referencing materials: conducted thorough referencing and linking for both promotional and non-promotional materials, supporting medical and regulatory compliance standards.
• Preparation of MOMs, SOPs, documenting project summaries and issues
• Carrying out ISO responsibilities based on set criteria and conducting checks monthly and publishing dashboards to the management.

Key Projects Handled:

• Localization of Global material: Led the adaptation of global promotional content for local market use on Zinc.
• Veeva testing for copy approval process: Played a key role in testing and validating the Veeva platform for copy approval workflow, identifying system gaps and recommending improvements.
• Zinc to Veeva migration: successfully managed the end-to-end migration process, ensuring data integrity and system compliance.

Pfizer Pharmacovigilance Process

• Case Processing and Data Entry Interacting with consumers, Physicians and other HCP's.
• Safety data management of Adverse Events. Case creation, Data entry & Duplicate check.
• Ensure data quality coding/standards are maintained. Use CDD for Pfizer drug coding and WHO Dictionary for coding other drug and Use MedDRA for Event coding.
• Identification of valid / invalid, serious / non-serious cases. Perform cross reference / cross linking of cases.
• Check consistency and accuracy of Argus and source document entry forms and make corrections as needed.
• Narrative Writing.