Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Manager Global Safety
What you will do
Let’s do this. Let’s change the world. In this vital role you will need to provide medical review of Individual Case Safety Reports (ICSRs) in support of safety surveillance for Amgen products. To support global individual case safety reports regulatory reporting compliance.
Supervision of 1-10 staff in Amgen India with responsibilities supporting medical review and Pharmacovigilance Operation activities as required.
To assure medical validity of ICSRs and provide expertise and guidance to the activities of Medical Safety Review Team (MSRT)
To implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
To act as a significant point of contact between Case Management and GSOs on medical content and regulatory reporting of ICSRs
Handling direct reports on a day-to-day basis and calling out topics as needed to GPS Senior Leadership.
Complete the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
Act as MSRT product lead as assigned
Implement ICSR case issue to Global Safety Officer (GSO) as appropriate
Complete appropriate case follow-up per SOPs
Support medical coding conventions, and systematic process improvements for ICSR medical review
Conduct reportability assessment for medical device associated events and/or product complaint associated events, and review for potential product problems.
Maintain list of expected terms in the auto label tool
Monitor the compliance of auto label tool updates (if applicable)
Support Quality Assurance of ICSR medical review (if applicable)
Support and lead activities for the training on and implementation of new processes in MSRT (if applicable)
Provide training to Amgen employees and vendor staff (if applicable) on ICSR medical review
Mentor junior medical reviewers. As needed and applicable, provide direct managerial responsibilities for medical reviewers on their functional team
Conduct reportability assessment for medical device associated events and/or product complaint associated events, and review for potential product problems.
Support MSRT vendor lead to handle vendor activities and support vendor training in ICSR medical review (if applicable)
Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, SOP creation, and metrics with regards to medical review
Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor
Inspection Readiness:
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
What we expect of you
Basic Qualifications:
Doctorate degree and 2 years of relevant experience OR
Master’s degree and 8 to 10 years of relevant experience OR
Bachelor’s degree and 10 to 14 years of relevant experience OR
Diploma and 14 to 18 years of relevant experience
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
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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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.