Global biotechnology leader Amgen is hiring for the position of Pharmacovigilance Operations Associate at its Hyderabad office. This opportunity is ideal for candidates with experience in pharmacovigilance, literature screening, literature review, drug safety operations, and Individual Case Safety Report (ICSR) identification.
Candidates with a background in life sciences and experience in literature surveillance or safety operations can apply for this exciting role and contribute to Amgen’s global drug safety and signal detection activities.
About the Role
The Pharmacovigilance Operations Associate will support Amgen’s global literature surveillance activities by reviewing scientific publications retrieved from bibliographic databases such as Embase, Medline, and BIOSIS. The role involves identifying potential safety signals, evaluating literature for Individual Case Safety Reports (ICSRs), and supporting periodic safety reporting activities.
This position plays a critical role in maintaining regulatory compliance and ensuring high-quality pharmacovigilance operations across Amgen’s product portfolio.
Key Responsibilities
Literature Management Activities
- Perform weekly review of literature articles imported into the literature citation management system.
- Identify literature citations that meet minimum criteria for Individual Case Safety Reports (ICSRs).
- Review publications for new aggregate safety information supporting periodic reports and signal detection activities.
- Determine whether full-text articles are required and initiate article requests when necessary.
- Flag publications containing new safety information for secondary review by Therapeutic Area Safety teams.
- Coordinate English translations of non-English articles through Local Safety Officers.
- Communicate relevant literature findings with business partners and internal stakeholders.
- Support regulatory inspections and pharmacovigilance audits.
Required Skills and Competencies
- Strong understanding of global pharmacovigilance regulations and literature surveillance processes.
- Ability to identify literature articles containing ICSR criteria and safety signals.
- Knowledge of bibliographic databases including Embase, Medline, and BIOSIS.
- Experience using literature citation management systems.
- Strong prioritization, communication, and time-management skills.
- Ability to incorporate feedback and continuously improve literature review quality.
- Exposure to Artificial Intelligence tools and prompt engineering will be an added advantage.
Educational Qualifications
Basic Qualifications
- Master’s degree with at least 1 year of pharmaceutical, biotechnology, or regulatory authority experience in a research and development setting.
OR
- Bachelor’s degree with 1-2 years of literature screening, literature review, pharmacovigilance, or relevant drug safety experience.
Preferred Qualifications
- Healthcare or Life Sciences professional with 2-3 years of relevant work experience.
- Minimum 1-2 years of direct literature review experience.
- Knowledge of bibliographic databases and literature screening methodologies.
Eligible Degrees: B.Pharm, M.Pharm, Pharm.D, B.Sc Life Sciences, M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research, Biomedical Sciences, Nursing, Medicine, and other allied healthcare disciplines.
Why Join Amgen?
- Opportunity to work with a leading global biotechnology company.
- Exposure to global pharmacovigilance operations and literature surveillance activities.
- Career growth in drug safety, signal detection, and regulatory sciences.
- Collaborative and innovation-driven work environment.
- Experience working with advanced safety technologies and AI-enabled processes.
- Competitive compensation and employee benefits.
Job Details
- Company: Amgen
- Position: Pharmacovigilance Operations Associate
- Job Type: Full-Time
- Location: Hyderabad, Telangana, India
- Department: Operations
- Work Mode: On-Site
- Job Requisition ID: R-248109
- Experience Required: 1-3 Years
- Industry: Biotechnology / Pharmacovigilance / Drug Safety
How to Apply
