Pharmacovigilance Operations Manager

Job description

Career Category Operations Job Description: HOW MIGHT YOU DEFY IMAGINATION?: 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. Pharmacovigilance Operations Manager LIVE: What you will do: In this vital role your primary responsibility will be a cting 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. Audit & externa...