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Amgen
Amgen is hiring for the position of Pharmacovigilance Operations Associate at its Hyderabad location. This is an excellent opportunity for life science professionals with experience in pharmacovigilance, literature review, and drug safety operations to join a globally recognized biopharmaceutical company.
The selected candidate will support Amgen’s Global Literature Surveillance team by reviewing scientific literature, identifying Individual Case Safety Reports (ICSRs), and contributing to signal detection activities for marketed products.
Job Details
Position: Pharmacovigilance Operations Associate
Location: Hyderabad, India
Job ID: R-248109
Work Mode: On-Site
Company: Amgen
Job Responsibilities
Literature Management Activities
- Review literature articles retrieved from Embase, Medline, and BIOSIS databases on a weekly basis.
- Identify and assess articles that meet the minimum criteria for Individual Case Safety Reports (ICSRs).
- Evaluate literature citations for new aggregate safety information supporting periodic safety reports and signal detection.
- Determine whether full-text articles are required and arrange procurement when necessary.
- Flag safety-related articles for secondary review by Therapeutic Area (TA) Safety teams.
- Coordinate translation requests for non-English publications through Local Safety Officers.
- Notify business partners regarding relevant literature findings when applicable.
- Support internal audits and regulatory inspections.
Pharmacovigilance & Safety Responsibilities
- Contribute to global literature surveillance activities across Amgen’s product portfolio.
- Support signal detection and safety monitoring processes.
- Ensure compliance with global pharmacovigilance regulations and company procedures.
- Maintain high-quality and timely completion of weekly literature reviews.
Required Skills & Knowledge
- Understanding of pharmacovigilance principles and global drug safety regulations.
- Ability to identify literature articles containing valid ICSR information.
- Experience reviewing scientific literature and safety-related publications.
- Knowledge of signal detection and aggregate safety data evaluation.
- Familiarity with literature citation management systems and bibliographic databases.
- Strong organizational and time management skills.
- Ability to manage multiple priorities and meet deadlines.
- Experience with AI tools and prompt-based technologies will be an added advantage.
Educational Qualification
Basic Qualification
- Master’s Degree with at least 1 year of experience in pharmaceutical, biotechnology, or regulatory authority environments.
OR
- Bachelor’s Degree with 1–2 years of literature screening, literature review, pharmacovigilance, or drug safety experience.
Preferred Qualification
- Healthcare or Life Science professional with 2–3 years of relevant experience.
- Minimum 1–2 years of direct literature review experience.
- Knowledge of bibliographic databases such as Embase, Medline, and BIOSIS preferred.
Why Join Amgen?
- Opportunity to work with a leading global biotechnology company.
- Exposure to advanced pharmacovigilance and drug safety operations.
- Participate in global literature surveillance and signal detection activities.
- Career growth within an internationally recognized research-driven organization.
- Collaborative work environment focused on patient safety and innovation.
How to Apply
Interested and eligible candidates can apply through Amgen’s official careers portal by searching for Job ID: R-248109 and submitting their application online.
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To apply for this job please visit careers.amgen.com.
