PHARMACOVIGILANCE OPERATIONS ASSOCIATE
Company: Amgen
Location: Hyderabad, India
Job ID: R-248109
Work Location Type: On-Site
Category: Operations
JOB OVERVIEW
The Pharmacovigilance Operations Associate supports Amgen's Global Literature Surveillance Program by reviewing scientific and medical literature to identify Individual Case Safety Reports (ICSRs) and potential safety signals across the company's marketed products. The role ensures compliance with global pharmacovigilance regulations and contributes to patient safety through effective literature monitoring.
GROUP PURPOSE
The team is responsible for global literature surveillance activities for all Amgen products. This includes reviewing literature articles for signal detection and identifying safety reports from scientific publications.
JOB PURPOSE
To perform routine literature screening and review activities using bibliographic databases such as Embase, Medline, and BIOSIS. The position supports signal detection activities and identification of adverse event reports from published literature.
KEY RESPONSIBILITIES
Literature Review & Surveillance
Review weekly literature search results imported into literature citation management systems.
Screen citations retrieved from Embase, Medline, and BIOSIS databases.
Assess literature articles for potential safety information.
Identify publications relevant to Amgen products.
Ensure timely completion of weekly literature reviews.
Individual Case Safety Report (ICSR) Identification
Determine whether literature articles meet minimum criteria for ICSR reporting.
Evaluate adverse event information reported in publications.
Identify reportable safety cases associated with marketed products.
Support case identification activities for pharmacovigilance operations.
Signal Detection Support
Review literature for new aggregate safety information.
Identify emerging safety trends and potential signals.
Support periodic safety reports and signal detection activities.
Flag relevant articles for Therapeutic Area (TA) Safety review.
Full-Text Article Management
Determine when full-text articles are required.
Request and obtain complete publications when necessary.
Review full-text articles to confirm ICSR eligibility or signal detection relevance.
Manage literature retrieval processes efficiently.
Translation & Communication
Coordinate English translations of non-English publications.
Work with Local Safety Officers for translation requests.
Notify business partners regarding relevant literature findings.
Communicate findings to appropriate stakeholders.
Quality & Compliance
Support internal audits and regulatory inspections.
Maintain compliance with global pharmacovigilance regulations.
Ensure high-quality literature review processes.
Incorporate feedback from Case Management and TA Safety teams.
KNOWLEDGE & SKILLS
Pharmacovigilance Skills
Literature Surveillance
Literature Screening
Signal Detection
Drug Safety Monitoring
Adverse Event Identification
ICSR Assessment
Aggregate Safety Review
Safety Signal Identification
Pharmacovigilance Compliance
Technical Knowledge
Embase
Medline
BIOSIS
Literature Citation Management Systems
Scientific Literature Databases
Safety Reporting Systems
Microsoft Office Applications
Regulatory Knowledge
Global Pharmacovigilance Regulations
Literature Surveillance Requirements
ICSR Reporting Guidelines
Signal Detection Processes
Drug Safety Compliance Standards
Additional Skills
Scientific Literature Evaluation
Analytical Thinking
Attention to Detail
Time Management
Prioritization Skills
Quality Review
Stakeholder Communication
Experience with AI tools and prompts (Preferred)
EDUCATIONAL QUALIFICATIONS
Required
Master's Degree in:
Pharmacy
Pharmacology
Life Sciences
Biotechnology
Clinical Research
Healthcare Sciences
OR
Bachelor's Degree in:
Pharmacy
Life Sciences
Biotechnology
Nursing
Related Healthcare Discipline
EXPERIENCE
Basic Requirements
Master's Degree with 1 year of pharmaceutical, biotech, or regulatory authority experience in R&D settings
OR
Bachelor's Degree with 1–2 years of literature screening, literature review, pharmacovigilance, or safety-related experience
Preferred Experience
2–3 years of relevant work experience
1–2 years of literature review experience
Drug Safety Operations experience
Pharmacovigilance experience
Bibliographic database experience
Signal Detection exposure
Medical Literature Review experience
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