Amgen Global Safety Manager- Affiliate (Country Safety Lead) in Bogota, Colombia
Managing the affiliate Safety team to ensure compliant and efficient performance of safety activities locally, based on sound knowledge of local legislative requirements and practice, Amgen policies and procedures, with an understanding of the business needs of the local affiliate.
Participating in exchange of safety information throughout the Amgen Global organisation to support informed understanding of product safety issues.
Being representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.
Working with Regional safety leads on process improvement initiatives or implementation of legislative changes.
Providing local Safety expertise to local stakeholders for review of plans / vendor contracts of local market research studies and patient support programmers to ensure safety contract language, training, monitoring and data collection are appropriately addressed.
Supporting the local implementation of risk minimization activities associated with approved risk management plans.
Facilitating exchange of adverse event information with functional service providers or business partners, or distributors
At least 5 years of experience in a similar role.
Fluent in English
Professional qualification as a health care professional (doctor, pharmacist, nurse, vet, etc.)
Knowledge of legislation which applies to safety practices locally
Thorough knowledge of local data privacy requirements
Understanding of relevant medical & safety terminology
Excellent organizational skills
Understanding of team dynamics
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.