Job Title: Global Periodic Reports Coordinator
Location: Hyderabad, India
Work Location Type: On-site
Date Posted: February 1, 2025
Category: Safety
Job Summary:
As a Global Periodic Reports Coordinator at Amgen, you will play a crucial role in the design, development, and implementation of policies and procedures for maintaining Amgen’s Periodic Aggregate Safety Reports (PASR) throughout the product lifecycle. You will ensure compliance and quality within the PASR process, generate key metrics, and provide training support to internal teams. Your role will include quality assurance, process oversight, and coordination of cross-functional collaboration to meet regulatory requirements and timelines.
Key Responsibilities:
Process Development and Oversight:
Contribute to the creation and continuous improvement of operating policies and procedures for the PASR team.
Maintain robust systems and processes to ensure compliance and quality standards are upheld.
Metrics and Reporting:
Generate, analyze, and assess PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
Evaluate the performance of PASR processes to ensure efficiency and effectiveness.
Quality Assurance:
Lead quality assurance activities to maintain high standards of accuracy and compliance in PASRs.
Training and Resource Management:
Maintain and update PASR training materials and Quick Reference Guides.
Oversee the management of training assignments within the Learning Management System (LMS) to ensure compliance with training requirements.
Act as a mentor and resource for team members involved in periodic reporting processes.
Collaboration and Support:
Serve as the central point of contact for Global Patient Safety on matters related to Amgen Regulatory Information Management (RIM).
Collaborate with and provide support to Global Periodic Report Scientists and other key stakeholders.
Coordinate and schedule meetings with cross-functional partners to ensure effective alignment on PASR activities.
Publishing and Submission:
Oversee the publishing and approval process for all PASRs, ensuring that all reports are submitted on time and in compliance with regulatory requirements.
Additional Responsibilities:
Assist with Integrated Case Management and coding activities as needed.
What We Expect from You:
Basic Qualifications:
Master’s degree and 1 to 3 years of relevant experience OR
Bachelor’s degree and 3 to 5 years of relevant experience OR
Diploma and 7 to 9 years of relevant experience
Skills and Competencies:
Strong organizational and communication skills to manage cross-functional collaboration.
Expertise in periodic reporting and pharmacovigilance processes.
Ability to manage and maintain quality assurance standards for safety reporting.
Proficiency in metrics generation and analyzing compliance indicators.
Ability to mentor and provide training to internal teams on regulatory and reporting processes.
What Amgen Offers:
Amgen supports your professional growth and well-being, offering competitive Total Rewards Plans aligned with local industry standards. As part of the Amgen team, you will be supported every step of the way in your career journey.
Gujarat :
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