In this vital role, you will be accountable for developing and executing the Global Pharmacovigilance Safety (GPS) strategy for safety-related organized data collection in Amgen clinical trials. Your work will ensure that Amgen's clinical trials comply with global regulatory safety requirements and adhere to Amgen's compliance policies and standards. You will collaborate closely with cross-functional teams, ensuring safety data collection processes are standardized and meet regulatory requirements across various clinical programs.
This role will involve participating in the review, approval, and execution of GPS safety data collection strategies across a wide range of clinical programs, including interventional studies, observational research, post-trial access, expanded access, and more.
Key Responsibilities :
1. Safety Data Collection Strategy :
- Accountable for the development of GPS strategy for safety-related organized data collection in Amgen clinical trials.
- Review, approve, and execute the GPS safety data collection strategy across clinical programs (e.g., interventional, observational research, non-Amgen sponsored clinical research, post-trial access, expanded access).
- Collaborate with cross-functional teams to ensure compliance with pharmacovigilance data collection standards and operational consistency for all Amgen products.
2. Cross-functional Collaboration :
Work with project teams to ensure safety data collection activities align with global safety legislation and regulatory requirements.Participate in the development and review of protocols, contracts, safety management plans , and investigative site study guidance documents to ensure compliance and alignment with Amgen's safety standards.Coordinate with vendors to ensure the timely and accurate reporting of all reportable safety event data in the clinical trial process.3. Administrative Support & Project Coordination :
Provide administrative support for project activities, schedules, and post items to project folders.Maintain up-to-date project information in relevant applications, ensuring smooth communication and coordination.Assist with the coordination of tasks and provide technical support to ensure the team's objectives are met.4. Vendor Oversight & Reconciliation :
Support clinical reconciliation activities and provide vendor oversight to ensure safety event data is reported in compliance with all regulatory requirements.Ensure consistent and accurate reporting of safety events across all teams and projects.Basic Qualifications :
Master's degree ORBachelor's degree with 2 years of Pharmaceutical Industry experience ORAssociate's degree with 6 years of Pharmaceutical Industry experience ORHigh school diploma / GED with 8 years of Pharmaceutical Industry experience .Preferred Qualifications :
Strong analytical skills to resolve day-to-day challenges effectively.Ability to apply a methodical approach to completing tasks and solving problems.Solid written and oral communication skills ; ability to clearly present information and actively listen at various organizational levels.Ability to work independently with minimal supervision while also being a collaborative team player.Demonstrated ability to learn quickly and adapt to new systems, processes, and tools .Highly organized, reliable, and responsive with attention to detail.Soft Skills :
Demonstrates Amgen's values in communication and action.Strong planning and organizational skills , applying a consistent approach to completing tasks.Ability to perform accurate, detailed work under time constraints.Comfortable managing multiple tasks and priorities simultaneously while maintaining high standards of excellence.What We Offer :
The opportunity to make a significant impact on the safety and compliance of Amgen's global clinical trials.A collaborative environment that fosters growth and innovation within the pharmaceutical industry.Competitive compensation with opportunities for career advancement.A comprehensive benefits package designed to prioritize employee well-being.Skills Required
Critical Thinking, Vendor Management, Decision Making, Data Collection, Technical Support
