Support interactions with business partners and vendors for all case intake and processing activities, ensuring vendor compliance with approved processes and training requirements
Job Summary
Support interactions with business partners and vendors for all case intake and processing activities, ensuring vendor compliance with approved processes and training requirements.
Accountable for the quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases.
Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards, supporting professional and personal growth.
Matching Summary
Support interactions with business partners and vendors for all case intake and processing activities, ensuring vendor compliance with approved processes and training requirements.
Skills & Requirements
Must-have
device/combination product ICSR processing
vendor oversight and compliance
regulatory authority reporting
Good Pharmacovigilance Practices
Nice-to-have
collaborative and innovative culture
science-based approach
passion for challenges
Key Requirements
Doctorate degree and 4 years of Drug Safety experience OR Master’s degree and 7 years of Drug Safety experience OR Bachelor’s degree and 9 years of Drug Safety experience
Pharmacovigilance or Quality experience in biotech, pharmaceutical or medical device industry
Understanding of global regulatory requirements (GMP, GVP)