Senior Associate Safety Data Analyst
Amgen · Hyderabad, India
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Role summary
This role supports pharmacovigilance operations by generating safety data outputs, maintaining system configurations, and ensuring data quality for regulatory reports and signal detection. The Senior Associate works with safety platforms like LifeSphere MultiVigilance and Argus, performing quality checks, participating in system implementations, and assisting with inspections and audits.
What they're looking for
- Master's degree, or Bachelor's degree with 2 years related experience, or high school diploma with 8 years related experience
- Knowledge of safety systems like LifeSphere MultiVigilance platform and Argus
- Proficiency with query and reporting tools such as Cognos or Tableau
- Understanding of global regulatory requirements for pharmacovigilance and safety reporting
- Experience supporting inspections, internal audits, or pharmaceutical industry work
- Familiarity with data warehouse concepts and statistical analysis of safety data
- Ability to work independently, manage priorities, and communicate cross-functionally
What you'll be doing
- Generate safety system outputs for periodic reports, signal detection, and regulatory inquiries
- Perform quality checks and peer reviews on data outputs and system configurations
- Participate in implementing routine system changes including reporting rules and study configurations
- Support study startup activities including RAVE-Argus mapping and user acceptance testing
- Contribute to technical solutions development and deliver training on safety database tools
Privacy & handoff
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