Pharmacovigilance Operations Manager

In this vital role your primary responsibility will be acting as US/EU local safety office and FDA/EMA point of contact for safety reporting. You will support the submission of all individual case safety reports to FDA/EMA, business partners (license partners) and vendors Supporting interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures. Ensuring vendor compliance with approved processes and training requirements.,

• Support ICSR processing to ensure high quality cases in a timely manner to meet all worldwide regulatory authority requirements
• Provide vendors with resources and training to perform their role
• Support the analysis and communication of case QC results
• Lead development and delivery of training materials for case management conventions
• Support resolution of case related specific queries
• Management of multiple business partner relationships for case management
• Support reviews of contract wording for case related data exchange
• Monitoring compliance regarding regulatory submissions and/or contractual wording for data exchange
• Assign tasks within Case Management to direct and indirect reports
• Support management of staff within Case Management
• Escalation of case processing issues
• Audit & external inspection support
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
• Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
• Day-to-day vendor management issues
• Interact with other local safety offices
• Ensure case processing timelines for AE intake, triage and submission are met
• Assess workload to assist in resource management
• Support on-boarding and on-going training of vendors
• Attend management meetings with vendors
• Support analysis of QC trends
• Support generating, communicating, and archiving of reports of QC findings
• Support audits of CAPAs and other actions/recommendations for ICSR quality related measures
• Perform case review as required
• Lead development and delivery of convention-related training material
• Support training of local office staff
• Perform US case follow up activities
• Perform BP reconciliation as required by safety agreement
• Generate and distribute performance metrics (submission compliance, volumes, turnaround times)
• Support reviews of contract wording for case related data exchange
• Support regulatory inspection and support for vendor audits/inspections
• Oversee performance monitoring and relay metrics to vendors
• Support analysis of QC trends including actions/recommendations
• Generate, communicate, and archive report of QC findings
Be part of our team You would be joining a dynamic, successful and cohesive team dedicated to achieving results, continuously exploring innovative approaches to success, all while ensuring the delivery of the best medicines to benefit patients.


• Understanding of global regulatory requirements for pharmacovigilance
• Project leadership experience
• Competence in safety systems
• Experience in supporting inspections or internal audits
• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
Education:
• Master's degree and 3 years of directly related experience or
• Bachelor's degree and 5 years of directly related experience or
• Associate's degree and 10 years of directly related experience or
• High school diploma / GED and 12 years of directly related experience
• Previous experience directly managing teams, projects, programs or directing the allocation of resources.
  
  If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.