Advertisement
Amgen is hiring a Pharmacovigilance Operations Manager for its Safety function in Hyderabad, India. This on-site, full-time role is ideal for experienced pharmacovigilance professionals with strong expertise in safety systems, regulatory reporting, PV analytics, and inspection readiness. The position plays a strategic role in supporting global safety databases, enabling compliant safety data outputs, and driving innovation through automation and AI in pharmacovigilance.
If you have hands-on experience with Argus / LifeSphere, aggregate safety reporting (PSUR, DSUR, PADER), and safety data analytics, this opportunity offers strong career progression in a global biopharmaceutical environment.
Key Responsibilities – Pharmacovigilance Operations Manager
Global Safety System & Data Support
- Support configuration and changes to global safety systems and safety data marts
- Ensure integrity, consistency, and reliability of pharmacovigilance safety data
- Participate in User Acceptance Testing (UAT) and system validation activities
- Collaborate with Safety Technology teams and Managed Services for system optimization
Safety Data Outputs & Regulatory Reporting
- Generate and review safety data outputs for PSUR, DSUR, PADER, audits, and inspections
- Configure user reports, Query By Example (QBE), and search strategies
- Perform quality checks, peer reviews, and ensure timely delivery of scheduled outputs
- Support signal detection and regulatory queries
Study & Integration Support
- Support study start-up activities and EDC–Safety Database integrations
- Review and approve Mapping Specification Worksheets (MSW)
- Execute and document UAT for study integrations
Automation, AI & Innovation in Pharmacovigilance
- Identify opportunities for AI-enabled safety case processing and reporting automation
- Support evaluation, validation, and governance of innovative PV technologies
- Partner with IT, Data Science, PV Operations, and Compliance teams
- Ensure regulatory compliance and inspection readiness for AI-enabled tools
Training, SOPs & Inspection Readiness
- Develop and deliver training for safety databases and reporting tools
- Contribute to SOPs, work instructions, and user manuals
- Support QPPV-delegated activities and regulatory inspections
Required Qualifications & Experience
Education
- Master’s degree, OR
- Bachelor’s degree with 2+ years of relevant experience, OR
- Associate degree with 6+ years, OR
- High school diploma with 8+ years of relevant experience
Experience & Skills
- Pharmaceutical industry or health authority experience (mandatory)
- Strong knowledge of pharmacovigilance regulations and safety reporting
- Experience with ArisGlobal LifeSphere / Argus Safety (preferred)
- Exposure to Cognos, Spotfire, Tableau, Oracle databases, PL/SQL, or Python
- Understanding of SDLC, system validation, and data warehousing
- Experience supporting audits, inspections, and regulatory submissions
- Strong communication, leadership, and cross-functional collaboration skills
Why Join Amgen?
- Global biopharmaceutical leader with strong safety culture
- Exposure to advanced PV systems, automation, and AI initiatives
- High-impact role supporting global regulatory compliance
- Competitive compensation and long-term career growth
- Work in a globally connected safety and technology ecosystem
Job Location & Work Type
- Location: Hyderabad, India
- Work Type: On-site
- Employment Type: Full-time
Estimated Salary (India)
- ₹18,00,000 – ₹28,00,000 per annum (CTC)
(Salary may vary based on experience, system expertise, and interview performance.)
How to Apply
Advertisement
Advertisement
