Job Summary:

To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)

Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports.

To act as a point of contact for Case Management on medical content of ICSRs

Key Activities:
Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
Execute ICSR case escalation as appropriate
Execute 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.
Support Quality Assurance of ICSR medical review (if applicable)
Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable)




Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her 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

Knowledge and Skills
Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance
Clinical knowledge of therapeutic area patient populations and drug class
Proficiency in technical safety systems including Safety Database and medical coding
Knowledge of safety data capture in Clinical Trials and Post Marketing setting
Knowledge of clinical trials and drug development
Knowledge of Amgen products and patient population (preferred)

Education Experience (Basic):

MD/DO or international equivalent and 1 year of related drug safety experience

Education Experience (Preferred):

MD/DO or international equivalent plus 3 years of relevant work

📌 Medical Review Senior Associate Scientist Telangana
🏢 AMGEN
📍 Telangana