As a Medical Review Senior Associate Scientist at Amgen, you will play a crucial role in ensuring the medical validity of individual safety case reports (ICSRs) to support global safety surveillance for Amgen products.
Responsibilities in the Job
As a key member of the safety team, your responsibilities will include:
- Supporting global ICSR regulatory reporting compliance.
- Assuring the medical validity of ICSRs and contributing to the Medical Safety Review Team (MSRT).
- Performing medical reviews of ICSRs, including narratives, coding, expectedness, causality, and seriousness to ensure quality reports.
- Acting as a point of contact for Case Management on medical content of ICSRs.
- Executing ICSR case escalation as appropriate.
- Conducting reportability assessments for medical device-associated events and product complaints.
- Supporting Quality Assurance of ICSR medical reviews (if applicable).
- Contributing to process improvements, SOP creation, and performance metrics related to medical review.
- Maintaining inspection readiness and serving as a representative for Health Authority Inspections and Internal Process Audits.
Qualifications
Basic Qualifications:
- Master’s degree with 1 to 3 years of relevant experience OR
- Bachelor’s degree with 3 to 5 years of relevant experience OR
- Diploma with 7 to 9 years of relevant experience
Preferred Qualifications:
- Knowledge of Amgen’s Medical Review and Case Management SOPs.
- Understanding of regulatory requirements for pharmacovigilance.
- Clinical knowledge of therapeutic areas and drug classes.
- Proficiency in technical safety systems, including safety databases and medical coding.
- Familiarity with safety data capture in clinical trials and post-marketing settings.
- Understanding of clinical trials, drug development, and Amgen’s product portfolio.
Essential Skills
- Strong analytical and problem-solving skills.
- Excellent medical writing and documentation capabilities.
- Proficiency in medical coding conventions and systematic process improvements.
- Ability to manage regulatory reporting compliance and safety case assessments.
- Strong communication and collaboration skills.
- Knowledge of pharmacovigilance regulations and best practices.
