Job Title: Global Periodic Reports - Senior Coordinator
Location: Hyderabad, India
Work Location Type: On-site
Date Posted: February 4, 2025
Category: Safety
Job Summary:
The Global Periodic Reports - Senior Coordinator at Amgen plays a pivotal role in overseeing the design, development, and implementation of operating policies for Periodic Aggregate Safety Reports (PASRs) throughout the product lifecycle. This position ensures compliance and quality while contributing to continuous improvement, generating metrics, leading quality assurance activities, and managing training resources related to PASRs.
Key Responsibilities:
Process Development and Oversight:
Contribute to the development and continuous improvement of policies and procedures for the PASR team.
Ensure systems and processes support compliance and quality throughout the PASR lifecycle.
Metrics and Reporting:
Generate and analyze PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
Report on metrics to assess compliance and performance.
Quality Assurance:
Lead quality assurance activities to ensure high standards of accuracy and compliance for PASRs.
Training and Resource Management:
Maintain and update training materials, Quick Reference Guides, and training assignment vehicles.
Oversee the management of PASR training in the Learning Management System (LMS) and ensure compliance across teams.
Serve as a mentor and centralized resource for training safety and corporate team members involved in PASR processes.
Collaboration and Coordination:
Act as the central point of contact for Global Patient Safety related to Amgen Regulatory Information Management (RIM).
Collaborate with and support Global Periodic Report Scientists and other stakeholders.
Coordinate and schedule meetings to ensure alignment and effective collaboration.
Publishing and Approval:
Lead the publishing and approval processes for PASRs to ensure timely and compliant submissions.
Inspection Readiness:
Maintain a state of inspection readiness, supporting audit and inspection deliverables, including information requests and responses.
Qualifications:
Basic Qualifications:
Doctorate degree OR
Master’s degree and 4-6 years of experience in pharmaceutical, biotech, or regulatory authority settings (research and development) OR
Bachelor’s degree and 6-8 years of experience OR
Diploma and 10-12 years of experience in the pharmaceutical, biotech, or regulatory authority industry.
Key Skills:
Strong strategic approach, attention to detail, and ability to work across multiple teams to ensure compliance and efficiency.
Knowledge of global pharmacovigilance regulations and periodic/aggregate reporting.
Good understanding of IT systems, document management systems (e.g., Veeva Vault), and industry standards.
Ability to manage priorities and timelines effectively.
Strong leadership, communication, and influencing skills in both oral and written formats.
Preferred Qualifications:
BS, RPH, RN, or Life Science degree with 5-8 years of directly relevant experience in Drug Safety.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | India | New Delhi | PAN-India |Assam :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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