Study Liaison Senior Associate

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

  OR

• Bachelor's degree

  with 2 years of

  Pharmaceutical Industry experience

  OR

• Associate's degree

  with 6 years of

  Pharmaceutical Industry experience

  OR

• High 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.