Sr. Associate Pharamocovigilance Operations
Amgen · Hyderabad, India
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Role summary
This role involves authoring, compiling, and peer-reviewing periodic aggregate safety reports for regulatory submission across multiple markets. The position coordinates cross-functional teams, manages timelines, ensures regulatory compliance, and maintains documentation throughout the report lifecycle. Based in Hyderabad, this senior-level safety operations position supports end-to-end development and submission of safety reports.
What they're looking for
- Experience authoring or compiling periodic aggregate safety reports
- Knowledge of global regulatory requirements for safety reporting
- Cross-functional collaboration and stakeholder management skills
- Quality control and peer review experience in safety documentation
- Familiarity with therapeutic area safety processes and guidelines
What you'll be doing
- Author and compile periodic aggregate safety reports across multiple formats
- Coordinate cross-functional meetings and manage report timelines with escalation
- Collect contributions from stakeholders and compile into standardized templates
- Conduct peer quality control review of safety content sections
- Manage report distribution and maintain regulatory compliance documentation
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.