Amgen Pharmacovigilance Operations Manager in Cambridge, United Kingdom
Pharmacovigilance Operations Manager
Amgen Pharmacovigilance Operations team are looking for an experienced Pharmacovigilance Operations Manager.
If you are looking for your next career step within Pharmacovigilance and want to be part of our mission – To serve patients – which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK http://careers.amgen.com/uk-ireland
Our Pharmacovigilance Operations Team primarily supports our case processing vendor based in India, with all case management related activities. The team also support interactions with Local Safety Officers, CROs and other internal PV Operations teams for all case processing activities. The team is responsible for vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures. They ensure vendor compliance with approved processes and training requirements, in addition to support process improvement initiatives and risk mitigation. They also provide audit & external inspection support.
Pharmacovigilance Operations Manager role overview :
Vendor oversight of all case processing activities.
Support Individual Case Safety Report (ICSR) processing to ensure high quality cases meet all worldwide regulatory authority requirements.
Act in the capacity of the workflow manager for ICSR oversight
Respond to Rave queries from clinical sites and data management / safety teams
Lead development and delivery of training materials for case management conventions.
Support resolution of case related specific queries ensuring case processing timelines are met.
Audit and external inspection support.
Support Case Management Sr. Managers by completing assigned routine and/or project specific tasks.
Escalate case processing issues to maintain a state of inspection readiness.
Interact with other local safety offices.
Submit all individual case safety reports to FDA and business partners (license partners) distributors.
Support analysis of Quality Control (QC) trends and generating, communicating and archiving of reports of QC findings.
Support audits, of CAPAs, and other actions and recommendations for ICSR quality related measures.
Develop and deliver convention-related training material and support training of local office staff.
Generate and distribute vendor performance metrics.
Qualifications and required experience:
Degree educated in relevant field
Previous managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Biotech, Pharmaceutical or Medical Device Industry experience
Working knowledge of global regulatory requirements for pharmacovigilance
Familiarity with end-to-end clinical development and commercialization processes
Ability to effectively represent ideas both verbally and in writing
Case processing experience and complete understanding of safety data capture, representation and interpretation
Proficiency in safety systems including Argus, Enterprise Imaging and support tools e.g. Excel, SharePoint, PowerPoint
Experience owning a business process and/or managing CAPA investigations
Demonstrated ability to identify process improvements
Demonstrated ability to train and support new and existing staff
Interfaces effectively with stakeholders and management to resolve issues
Able to organize, plan, and prioritize workload
Understanding of global regulatory requirements for pharmacovigilance
Competence in safety systems and medical coding
Experience in supporting inspections or internal audits
Location: Uxbridge or Cambridge
Competitive salary & comprehensive benefits package including bonus scheme
About our company:
Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.