Pharmacovigilance Operations Manager Job At Amgen
The Pharmacovigilance Operations Manager role at Amgen offers a strategic opportunity to support global safety systems, regulatory reporting, and innovative pharmacovigilance technologies. Based in Hyderabad, this Pharmacovigilance Job role focuses on safety data integrity, inspection readiness, automation, and AI-driven advancements within a highly compliant global safety environment. Graduates seeking Pharmacy Jobs and want to start their career with Pharmacy Careers.
Job Details
- Job Title: Pharmacovigilance Operations Manager
- Location: Hyderabad, India
About the Company
Amgen is a global biotechnology company committed to advancing science to improve lives. With a strong focus on ethics, innovation, and patient safety, Amgen integrates cutting-edge technology, data analytics, and regulatory excellence to deliver high-quality medicines while maintaining the highest standards of compliance worldwide. This Pharmacovigilance Job role plays a significant role in the company.
Educational Requirements
- Master’s degree OR
- Bachelor’s degree with 2 years of directly related experience OR
- Associate degree with 6 years of directly related experience OR
- High school diploma/GED with 8 years of directly related experience
Key Responsibilities for this Pharmacovigilance Job
- Support global safety system changes, configurations, and data mart maintenance
- Ensure integrity, consistency, and reliability of safety data for analytics and reporting
- Generate and quality-check safety data outputs for regulatory reports (PADER, PSUR, DSUR), audits, and inspections
- Support study start-up activities including EDC to safety database mapping and UAT execution
- Configure safety systems to enable routine and automated safety reporting
- Identify and support automation, AI, and advanced analytics initiatives in pharmacovigilance
- Participate in training development for safety databases and reporting tools
- Support compliance activities delegated by the QPPV and maintain inspection readiness
- Act as a point of contact during health authority inspections and internal audits
Skills Required for this Pharmacovigilance Job
- Knowledge of pharmacovigilance safety systems (preferably ArisGlobal LifeSphere)
- Experience with reporting and analytics tools such as Cognos, Spotfire, or Tableau
- Working knowledge of Oracle databases and programming languages (Python, PL/SQL)
- Understanding of global pharmacovigilance regulations and safety reporting requirements
- Familiarity with SDLC, system validation, and audit readiness
- Strong analytical, organizational, and problem-solving skills
- Effective cross-functional communication and leadership abilities
Why This Job Role?
This pharmacovigilance job role offers the chance to work at the intersection of pharmacovigilance, data analytics, and innovation within a globally respected biotech organization. It is ideal for professionals seeking leadership exposure, regulatory impact, and hands-on involvement with AI-driven safety solutions while ensuring patient safety and compliance at scale. Graduates seeking Pharmacy Jobs and want to start their career with Pharmacy Careers.
