Medical Review Senior Associate Scientist
Organization: Amgen
Location: Hyderabad, India
Work Location Type: On-Site
Job ID: R-235713
Department: Global Patient Safety – PV Operations
Category: Safety
Date Posted: February 11, 2026
About the Role
Amgen is seeking a Medical Review Senior Associate Scientist to support global pharmacovigilance operations and ensure regulatory compliance in safety surveillance activities. The role focuses on reviewing Individual Case Safety Reports (ICSRs), ensuring medical accuracy, and contributing to safety monitoring processes for Amgen products. The selected candidate will collaborate with cross-functional teams to maintain the highest standards of drug safety, regulatory compliance, and quality reporting.
Amgen maintains strict ethical standards across all business practices. Applicants are expected to provide accurate and complete information throughout the hiring process. Any false or misleading information may result in disqualification or termination.
Key Responsibilities
Ensure medical validity of Individual Case Safety Reports (ICSRs) and provide expert input to the Medical Safety Review Team (MSRT).
Perform comprehensive medical review of ICSRs, including narratives, coding, expectedness, causality, and seriousness assessments.
Act as a subject matter expert and point of contact for case management teams on medical aspects of ICSRs.
Execute case escalations and perform follow-up activities in accordance with standard operating procedures (SOPs).
Maintain high-quality, medically accurate safety reports to support global regulatory compliance.
Support medical coding standards and drive process improvements in ICSR medical review workflows.
Conduct reportability assessments for medical device-related events and product complaints, including evaluation of potential product issues.
Contribute to quality assurance processes for ICSR medical review where applicable.
Participate in cross-functional initiatives, including process improvements, SOP development, and performance metrics related to safety review operations.
Perform additional responsibilities as defined by SOPs or assigned by supervisors.
Inspection Readiness and Compliance
Support activities delegated by the Qualified Person for Pharmacovigilance (QPPV) and maintain inspection readiness.
Serve as a representative or point of contact for health authority inspections and internal process audits within assigned responsibilities.
Required Knowledge and Skills
Strong understanding of pharmacovigilance regulations, medical review processes, and case management procedures.
Clinical knowledge of therapeutic areas, patient populations, and drug classifications.
Proficiency in safety databases, medical coding systems, and technical safety platforms.
Knowledge of safety data collection in clinical trials and post-marketing environments.
Understanding of drug development processes and clinical research methodologies.
Familiarity with Amgen products and patient populations is preferred.
Education and Experience Requirements
Basic Qualifications:
MD, DO, or international equivalent qualification.
Minimum 1 year of relevant experience in drug safety or pharmacovigilance.
Preferred Qualifications:
MD, DO, or international equivalent qualification with 3 or more years of relevant professional experience in pharmacovigilance, drug safety, or medical review.
Why Join Amgen
This role offers the opportunity to contribute to global patient safety initiatives within a highly regulated environment, ensuring the delivery of safe and effective therapies through robust pharmacovigilance practices. Candidates will gain exposure to global regulatory frameworks, cross-functional collaboration, and advanced safety monitoring systems.
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Zaventem |South America :
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Manila |Croatia :
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