Amgen Hiring Sr Associate Pharmacovigilance Operations – ₹12 LPA Salary | FDA & EMA Safety Jobs in India

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Amgen Hiring Sr Associate Pharmacovigilance Operations – Hyderabad | ₹12 LPA | US/EU Safety

Amgen

Hyderabad

2+ Years

Pharmacovigilance

Full-Time

📄 Job Overview

Amgen, a global biopharmaceutical leader, is hiring a Senior Associate – Pharmacovigilance Operations for its Medical Services team in Hyderabad.

This on-site role offers hands-on exposure to US/EU safety reporting, ICSR submissions, FDA & EMA compliance in a highly regulated global pharmacovigilance environment.

🧪 Role: Sr Associate – Pharmacovigilance Operations

Location: Hyderabad (On-site)

Experience: 2+ Years Pharmacovigilance

Key Responsibilities:

• Act as US/EU local safety office & FDA/EMA point of contact
• Submit ICSRs to FDA, EMA & business partners
• Perform case review, QC & escalation of safety issues
• Ensure timely expedited reporting as per regulations
• Support vendor oversight & safety reconciliation
• Manage intake, triage & data entry queries
• Provide LAO E2B support (nullification & redistribution)
• Support audits, inspections & inspection readiness
• Assist QPPV delegated activities
• Support PV trainings & SOP compliance

📌 Key Activities

• Review non-matching safety data across databases
• Oversee vendor clinical safety reconciliation teams
• Perform US case follow-up activities
• Select cases for FDA/EMA reporting
• Initiate unblinding requests when required
• Support ICSR literature review processes
• Ensure compliance with global PV regulations

🎓 Eligibility & Experience

• B.Pharm / M.Pharm / Pharm.D
• BSc / MSc – Life Sciences / Biotechnology / Clinical Research
• Bachelor’s + 2 Years PV experience (OR)
• Associate degree + 6 Years experience (OR)
• High School + 8 Years PV experience

🧠 Required Skills

• Strong knowledge of global pharmacovigilance regulations
• Hands-on experience in ICSR processing & reporting
• Understanding of clinical development processes
• High attention to detail & case quality
• Proficiency in safety databases & MS Office

💰 Salary (Estimated)

• ₹8,00,000 – ₹12,00,000 per annum
• Based on experience & industry standards
• Strong career growth in global PV operations

📌 Note Before You Apply:
Kindly read the complete job description carefully. Ensure your pharmacovigilance experience aligns with US/EU safety reporting before applying.

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