Data & Conformance Manager, Associate

Pfizer Inc; Colombia; Híbrido; COP 90.000.000 - 130.000.000; Jornada completa

Descripción de la vacante

Pfizer is seeking a Data & Conformance Manager to interpret, manage, and ensure the quality and proper management of global regulatory data and conformance activities across geographies, functions and divisions. This role ensures data integrity and timely updates within SOPs and processes for regulatory compliance.

Work location is Hybrid. The position requires coordinating data systems updates, aiding local and regional regulatory initiatives, and supporting the portfolio with flexible data

Responsabilidades

• Review and interpret regulatory data to establish systems and SOPs for data scope.
• Maintain HA status in dossier management system for Regions/Markets.
• Update regulatory systems for CMC events upon submission/approval evidence.
• Perform data entry and quality control in global regulatory systems.
• Adhere to quality control procedures to ensure regulatory compliance.

Descripción del empleo

JOB SUMMARY

The Data & Conformance Manager focus within Regulatory Data & Conformance Management (RDCM) is to interpret, manage and ensure the quality, accuracy, and proper management of global regulatory data and conformance activities received across different geographies, functions and divisions. Ensuring key activities and regulatory systems updates are completed whilst adhering to all policies, practices and procedures. These activities ensure data integrity to enable the organization to have visibility across all functions within a products lifecycle. It is essential that all systems are clearly and accurately updated within the timelines specified in the Standard Operating Procedures (SOPs) or business process documentation to ensure regulatory compliance. Work Location Assignment: Hybrid

RESPONSIBILITIES

• Review and interpret the data provided by GRS to establish the system / tools required to be populated in line with current standard operating procedures or business process documentation, including systems and SOPs associated with the regulatory data scope.
• Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
• Responsible for making updates in regulatory systems for all the CMC events upon receipt of notification of Submission and Approval evidence
• Perform data entry and quality control tasks associated in all global regulatory systems impacted, including systems associated with the regulatory data scope.
• Adhering to quality control procedures and standards related to the systems or tools ensuring Regulatory Compliance
• Support global/local team members with data management workload when necessary to provide flexible support for the portfolio.
• Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values
• Assist in ensuring internal regulatory processes and procedures are well documented
• Support the teams in ADHOC activities including assisting presentations / review of metrics
• Makes timely decisions on straight cases within guidelines and policies

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Regulatory Affairs