Senior Associate, Pharmacovigilance Operations - Remote

Overview

This position plays a crucial role in the authoring, compilation, and peer review of Amgen’s Periodic Aggregate Safety Reports (PASR) in compliance with global regulatory requirements, supporting the end-to-end writing and documentation process.

In Short

• Compile and author Periodic Aggregate Safety Reports (PASRs).
• Coordinate meetings with cross-functional stakeholders for effective collaboration.
• Drive report timelines and escalate risks or delays.
• Collaborate with stakeholders to collect PASR contributions.
• Author safety content in collaboration with Therapeutic Area Safety scientists.
• Conduct peer quality control of safety authored sections.
• Manage report distribution to Contract Research Organizations (CROs).
• Ensure adherence to regulatory guidelines and timelines.
• Maintain accurate records and documentation throughout the process.
• Generate PASR metrics including Key Compliance Indicators (KCIs).

Requirements

• Master’s degree or Bachelor's degree with 5 years of experience.
• Knowledge of regulatory guidelines and industry standards.
• Experience in pharmacovigilance operations.
• Strong organizational skills and attention to detail.
• Ability to collaborate with cross-functional teams.
• Excellent written and verbal communication skills.
• Experience in documentation and quality control processes.
• Proficiency in generating metrics and reports.
• Ability to manage timelines and escalate issues effectively.
• Familiarity with literature management processes is a plus.

Benefits

• Opportunity to work with a leading biotechnology company.
• Engagement in meaningful work that improves health outcomes.
• Access to advanced tools and technologies in the field.
• Professional development and growth opportunities.
• Collaborative and innovative work environment.
• Competitive salary and benefits package.
• Flexible working arrangements.
• Contribution to impactful projects in healthcare.
• Networking opportunities within the industry.
• Commitment to employee well-being and support.