Hyderabad, Telangana Amgen Jobs – 459 Open Jobs Today

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Pharmacovigilance Operations Associate

Amgen -
Hyderabad, Telangana

Apply Now

Job details

5 days ago

Qualifications

English
Master's degree
Databases
Bachelor's degree
AI
Research & development

Full job description

India - Hyderabad

JOB ID: R-248109 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jun. 18, 2026 CATEGORY: Operations

Group Purpose

Group is accountable for global literature surveillance activities for all Amgen portfolio of products. Responsible for performing the weekly review of literature articles for signal detection and identification of safety reports.

Job Summary

This position is responsible for performing routine weekly review of literature articles retrieved from Embase, Medline, and BIOSIS, which are the bibliographic databases used for Amgen’s global literature surveillance. The review supports signal detection for all Amgen portfolio of products and identification of individual case safety reports (ICSRs) for marketed products.

Key Activities

Key Responsibilities:

Literature Management Process
Perform review of literature results retrieved and imported into literature citation management system on a weekly basis and determine if minimum criteria for ICSR is met for marketed products
Perform review of literature results to determine if article contains new aggregate safety information in support of the periodic report and/or signal detection
Determine whether full text article needs to be ordered and order them if further information is needed to confirm if citation meets criteria for ICSR or for signal detection
Flag articles containing new aggregate safety information for TA Safety to perform secondary review
Request Local Safety Officer to provide English translation if the article is not in English
Notify business partner of articles received, if applicable
Support audits and inspections

Knowledge and Skills

Ability to identify literature articles containing ICSR criteria or aggregate safety findings supporting signal detection
Ability to order full text articles where needed
Ability to receive feedback from Case Management and TA Safety and optimize quality of literature review
Demonstrate knowledge of global aspects of pharmacovigilance
Strong knowledge of processes and global regulations for pharmacovigilance and literature surveillance
Ability to effectively manage competing priorities and timelines
Strong knowledge of literature citation management systems and platform used to configure search strategies
Experience in use of AI and prompts would be useful

CONTRIBUTION:

Ensures Amgen remains in compliance and maintain high quality global literature review process
Responsible for timely completion of review of weekly literature results

Education & Experience (Basic)

Master’s degree and 1 year of pharmaceutical, biotech or regulatory authority experience in a research and development setting

OR Bachelor’s degree and 1- 2 years of Literature screening/Review or relevant Safety experience

Education & Experience (Preferred)

Health Care/Lifescience Professional with minimum 2 - 3 years of relevant work experience including 1 to 2 years of experience in literature review

Knowledge of bibliographic databases and direct literature review experience preferred.

Apply Now

Refine Your Search

amgen jobs in hyderabad, telangana

Pharmacovigilance Operations Associate

Associate Quality Complaints

Data Delivery Lead

Executive Director, Site Head, Amgen Genome Valley (AGV)

Sr. Associate Quality Complaints

Manager-Analytical & Data Verification

Specialist QA, Global Supply Quality

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Senior Associate, Data Analytics Supply Chain

Data Management Associate

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