Senior Manager Global Safety

What you will do

Lets do this. Lets 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
• Masters degree and 8 to 10 years of relevant experience OR
• Bachelors degree and 10 to 14 years of relevant experience OR
• Diploma and 14 to 18 years of relevant experience