Job Title: Medical Review Scientist
Location: Hyderabad, India
Work Location Type: On-site
Date Posted: February 4, 2025
Category: Safety
Job Summary:
As a Medical Review Scientist at Amgen, you will be responsible for providing medical review of individual case safety reports (ICSRs) to support safety surveillance for Amgen products. Your role will ensure regulatory compliance and quality in reporting, collaborating closely with various teams to guarantee medically accurate case assessments.
Key Responsibilities:
Medical Review of ICSRs:
Implement the medical review of ICSRs, focusing on narratives, coding, expectedness, causality, and seriousness.
Ensure that all reports are medically valid and accurate.
Regulatory Compliance:
Support global regulatory reporting compliance for ICSRs.
Ensure adherence to Amgen’s pharmacovigilance standards and regulatory requirements.
Collaboration:
Act as a key contact for Case Management regarding the medical content of ICSRs.
Provide support for the Medical Safety Review Team (MSRT) and MSRT Product Leads, including the escalation of cases when appropriate.
Process Improvement:
Support and drive improvements in medical coding conventions and ICSR medical review processes.
Conduct reportability assessments for product-related issues and device complaints.
Mentoring and Training:
Mentor junior medical reviewers and support training for vendor staff, if applicable.
Participate in Safety Assessment Teams (SAT) and contribute to cross-functional initiatives aimed at process improvements.
Inspection Readiness:
Maintain a state of inspection readiness, supporting Health Authority Inspections and Internal Audits as needed.
Undertake delegated activities as outlined in the PV System Master File.
Qualifications:
Basic Qualifications:
Doctorate degree OR
Master’s degree and 4-6 years of relevant experience OR
Bachelor’s degree and 6-8 years of relevant experience OR
Diploma and 10-12 years of relevant experience.
Preferred Qualifications:
Knowledge of Amgen’s Medical Review SOPs and regulatory requirements for pharmacovigilance.
Strong clinical knowledge of therapeutic areas and drug classes.
Proficiency in safety systems and medical coding (familiarity with Amgen Safety Database preferred).
Understanding of safety data capture in clinical trials and post-marketing environments.
Experience with Amgen products and patient populations is an advantage.
What Amgen Offers:
Amgen offers a collaborative and innovative work environment, supporting your personal and professional growth. In addition to a competitive base salary, Amgen provides comprehensive Total Rewards Plans aligned with industry standards, promoting well-being and career development.
Gujarat :
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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