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Literature Review Specialist

8-13 years
₹13–20 LPA
10 July 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Literature Review Specialist
Location: Hyderabad, India
Job ID: R-219483
Posted On: June 30, 2025
Work Type: On-Site | Full-Time
Category: Safety


About Amgen:

Amgen is a global biotechnology leader dedicated to using science and innovation to serve patients suffering from serious illnesses. With major therapeutic focus in Oncology, Inflammation, General Medicine, and Rare Disease, Amgen delivers transformative medicines worldwide. Be a part of a team that pioneers solutions for the world’s toughest health challenges.


Role Summary:

As a Literature Review Specialist, you will play a critical role in Amgen’s global literature surveillance process. You will be responsible for evaluating scientific literature to detect safety signals and identify ICSRs for all Amgen products. This position demands high attention to detail, strong knowledge of pharmacovigilance regulations, and experience in handling bibliographic databases.


Key Responsibilities:

Literature Surveillance:

  • Conduct weekly reviews of literature retrieved from databases (Embase, Medline, BIOSIS).

  • Assess if articles meet ICSR criteria or contain new aggregate safety information.

  • Flag relevant content for further safety team review.

  • Request and evaluate full-text articles or English translations as needed.

  • Provide training and support to junior reviewers.

Quality & Compliance:

  • Perform retrospective quality checks of team’s literature reviews.

  • Assist in the development and execution of process improvement initiatives.

  • Collaborate with Case Management and Therapeutic Area Safety for review optimization.

  • Support audits and inspections by retrieving citation data.

Periodic Safety Reporting:

  • Extract citation lists for periodic safety reports (e.g., DSUR, PBRER).

  • Support quality control processes for safety documentation.


Key Skills & Knowledge:

  • Deep understanding of pharmacovigilance regulations and literature review protocols.

  • Proficiency in bibliographic databases (Embase, Medline, BIOSIS).

  • Strong working knowledge of literature citation management systems.

  • Ability to prioritize multiple tasks and adhere to tight deadlines.

  • Familiarity with AI tools and prompt-based search strategies is advantageous.


Qualifications:

  • Education: Bachelor's or Master’s degree in Life Sciences, Pharmacy, or related field.

  • Experience: 8–13 years in pharmaceutical, biotech, or regulatory authority environment, with direct literature review experience preferred.


Estimated Salary: ₹13–20 LPA (based on experience and role seniority)