Medical Review Senior Associate Scientist – Global Patient Safety
Location: Hyderabad, India | Job Type: Full-Time | Category: Pharmacovigilance / Safety
About the Role
Amgen is seeking a Medical Review Senior Associate Scientist to join our Global Patient Safety team in Hyderabad. This role is pivotal in ensuring the medical accuracy and compliance of Individual Case Safety Reports (ICSRs) across our global pharmacovigilance operations. The position supports regulatory reporting compliance and contributes to the ongoing improvement of medical review processes.
As a key member of the Medical Safety Review Team (MSRT), you will be responsible for reviewing and validating ICSRs, providing clinical insights, and ensuring high-quality reporting in alignment with Amgen standards and regulatory requirements.
Key Responsibilities
Medical Review & Case Management
Perform medical review of ICSRs, including narrative assessment, coding, causality, expectedness, and seriousness, ensuring medically accurate reports.
Provide clinical input and act as a point of contact for case management teams regarding ICSR content.
Execute ICSR case escalation and follow-up per SOPs to ensure comprehensive case documentation.
Conduct reportability assessments for medical device-related events or product complaints and identify potential product safety concerns.
Support quality assurance activities for ICSR medical review, ensuring adherence to Amgen standards and continuous process improvement.
Process Improvement & Compliance
Contribute to cross-functional initiatives, including SOP development, metrics, and medical review process enhancements.
Maintain up-to-date knowledge of regulatory requirements, pharmacovigilance best practices, and therapeutic area patient populations.
Ensure inspection readiness by supporting Health Authority audits, internal process audits, and delegated QPPV activities.
Stakeholder Collaboration
Collaborate with internal teams, including Clinical Operations, Regulatory, and PV Operations, to ensure accurate and timely medical safety assessments.
Provide guidance on medical review processes and coding conventions to support global safety operations.
Qualifications & Experience
Required:
MD, DO, or international equivalent.
Minimum 1 year of relevant drug safety/pharmacovigilance experience.
Knowledge of clinical trials, drug development, and patient populations.
Familiarity with ICSR management, medical coding, and pharmacovigilance SOPs.
Strong clinical judgment and ability to interpret safety data accurately.
Preferred:
MD, DO, or international equivalent with 3+ years of relevant pharmacovigilance experience.
Experience with medical review in both clinical trial and post-marketing settings.
Knowledge of Amgen products and therapeutic areas.
Skills:
Excellent verbal and written communication.
Proficiency in safety databases and technical systems for pharmacovigilance.
Strong analytical skills, attention to detail, and ability to manage multiple priorities.
Collaborative mindset with the ability to work in cross-functional teams.
Why Amgen?
At Amgen, we are dedicated to improving patient outcomes through innovative therapies. Joining our Global Patient Safety team offers the opportunity to work at the forefront of drug safety, impact patient health worldwide, and contribute to a culture of quality, compliance, and clinical excellence.
Amgen is committed to ethical hiring practices, diversity, equity, inclusion, and accessibility. Applicants requiring accommodation during the recruitment process are encouraged to contact Amgen directly.
Apply Now to be part of a global team ensuring patient safety and pharmacovigilance excellence.
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