Medical Review Senior Associate Scientist – Pharmacovigilance | Full Time Job in Hyderabad
Company: Amgen
Department: Global Patient Safety – PV Operations
Job Category: Drug Safety / Pharmacovigilance
Job ID: R-235713
Work Location: On-site
Experience Required: 1–3+ Years in Drug Safety or Pharmacovigilance
Advance your career in pharmacovigilance and global drug safety with a leading biotechnology organization focused on improving patient outcomes through scientific innovation. This role provides an opportunity to contribute to global safety surveillance, individual case safety report review, and regulatory compliance within a high-impact healthcare environment.
Job Overview
The Medical Review Senior Associate Scientist is responsible for performing medical review of Individual Case Safety Reports (ICSRs) to support global pharmacovigilance activities and safety surveillance. The role ensures medical accuracy, regulatory compliance, and high-quality safety reporting for pharmaceutical products.
The position involves evaluating clinical safety data, reviewing case narratives, assessing causality and seriousness, and supporting safety monitoring processes. The candidate will also collaborate with cross-functional teams to strengthen medical review processes and maintain inspection readiness.
Key Responsibilities
Perform medical review of Individual Case Safety Reports (ICSRs), including narrative evaluation, coding validation, expectedness, causality, and seriousness assessment.
Ensure medical validity and quality of safety case reports in compliance with pharmacovigilance standards.
Provide medical input to Medical Safety Review Team activities.
Act as a subject matter contact for case management teams regarding medical content of safety reports.
Escalate safety cases and conduct follow-up activities in accordance with standard operating procedures.
Support medical coding practices and continuous process improvements in safety case review.
Assess reportability of medical device events and product complaint–related safety cases.
Contribute to quality assurance activities for medical review processes.
Participate in cross-functional initiatives including process improvement, standards development, and SOP creation.
Support regulatory inspection readiness and maintain compliance with pharmacovigilance system requirements.
Serve as a point of contact during health authority inspections and internal audits where applicable.
Perform additional pharmacovigilance duties as required by the organization.
Required Skills and Competencies
Strong knowledge of pharmacovigilance processes, drug safety regulations, and case management procedures.
Understanding of clinical trial safety data capture and post-marketing surveillance activities.
Clinical knowledge of therapeutic areas, drug classes, and patient populations.
Experience working with safety databases and medical coding systems.
Understanding of clinical research and drug development lifecycle.
Strong analytical, documentation, and regulatory compliance skills.
Ability to work collaboratively within cross-functional teams.
Educational Qualifications and Experience
Basic Requirements:
MD, DO, or international equivalent medical degree.
Minimum 1 year of experience in drug safety, pharmacovigilance, or related field.
Preferred Requirements:
MD, DO, or equivalent with 3+ years of relevant pharmacovigilance or medical safety experience.
Knowledge of biotechnology or pharmaceutical product safety processes.
Work Environment
Full-time on-site position based in Hyderabad, India.
Role involves collaboration with global safety and regulatory teams.
Requires adherence to global regulatory and quality standards.
About the Organization
Amgen is a global biotechnology company dedicated to discovering, developing, and delivering innovative human therapeutics. The organization focuses on advancing scientific research, maintaining high ethical standards, and improving patient care through cutting-edge medicines and safety-driven processes.
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