Senior Manager Global Safety

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.