Pharmacovigilance Operations Associate
Company: Amgen
Location: Hyderabad, India
Job ID: R-248109
Work Mode: On-Site
Department: Operations
Posted On: 18 June 2026
Job Summary
The Pharmacovigilance Operations Associate is responsible for conducting weekly reviews of scientific literature retrieved from bibliographic databases such as Embase, Medline, and BIOSIS. The role supports global literature surveillance activities, signal detection, and identification of Individual Case Safety Reports (ICSRs) across Amgen's product portfolio.
Key Responsibilities
Literature Management
Review weekly literature search results and determine whether minimum ICSR criteria are met for marketed products.
Assess literature articles for new aggregate safety information relevant to periodic safety reports and signal detection activities.
Request and obtain full-text articles when additional information is required.
Flag articles containing potential safety signals for secondary review by Therapeutic Area (TA) Safety teams.
Coordinate English translations for non-English publications through Local Safety Officers.
Notify relevant business partners regarding received articles when applicable.
Support regulatory inspections, audits, and compliance activities.
Pharmacovigilance Activities
Identify literature articles containing valid adverse event reports and safety findings.
Ensure accurate and timely literature screening according to global pharmacovigilance regulations.
Incorporate feedback from Case Management and Safety teams to improve review quality.
Maintain compliance with global literature surveillance processes and reporting timelines.
Required Skills & Knowledge
Strong understanding of Pharmacovigilance (PV) processes and global safety regulations.
Knowledge of literature surveillance and bibliographic databases (Embase, Medline, BIOSIS).
Ability to identify ICSR-reportable cases and aggregate safety information.
Experience with literature citation management systems.
Strong attention to detail and time-management skills.
Ability to manage multiple priorities and meet strict deadlines.
Familiarity with AI tools and prompt-based technologies is an added advantage.
Education & Experience
Basic Qualification
Option 1
Master's Degree in Life Sciences, Pharmacy, Healthcare, or related field.
Minimum 1 year of pharmaceutical, biotechnology, CRO, or regulatory authority experience.
OR
Option 2
Bachelor's Degree in Life Sciences, Pharmacy, Healthcare, or related field.
1–2 years of literature screening, literature review, pharmacovigilance, or drug safety experience.
Preferred Qualification
Healthcare or Life Sciences professional.
2–3 years of relevant industry experience.
1–2 years of direct literature review or literature surveillance experience.
Experience with bibliographic databases and pharmacovigilance literature screening.
Key Contribution
Ensure compliance with global literature surveillance requirements.
Deliver high-quality and timely literature reviews.
Support signal detection and safety monitoring activities across Amgen's product portfolio.
Salary Criteria
Expected Salary: ₹5.5–8.5 LPA for candidates with 1–3 years of Pharmacovigilance/Literature Review experience, depending on qualifications, skills, and relevant industry exposure.
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