Instagram
youtube
Facebook

Study Liaison Senior Associate

2+ years
Not Disclosed
10 Feb. 17, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Study Liaison Senior Associate

Location: Hyderabad, India
Work Location Type: On-site
Date Posted: February 4, 2025
Category: Safety


Job Summary:

As a Study Liaison Senior Associate at Amgen, you will be responsible for the development of the GPS strategy for safety-related organized data collection in clinical trials. This role ensures that clinical programs comply with global regulatory requirements and Amgen's compliance policies. You will collaborate with cross-functional teams to ensure the execution of safety data collection strategies and operational consistency across clinical programs for Amgen products.


Key Responsibilities:

  • Safety Data Collection Strategy:

    • Develop and execute the GPS safety data collection strategy across clinical programs, including interventional, observational research, and non-Amgen sponsored clinical research.

    • Ensure compliance with pharmacovigilance data collection standards in clinical trials.

  • Cross-functional Coordination:

    • Collaborate with project teams and managers to ensure seamless coordination and adherence to timelines.

    • Provide technical support to ensure the execution of the group's objectives.

  • Protocol and Contract Development:

    • Contribute to the development of protocols, contracts, safety management plans, and investigative site study guidance documents.

  • Clinical Reconciliation & Vendor Oversight:

    • Support clinical reconciliation activities and vendor oversight to ensure that all reportable safety event data is accurately captured and reported.

  • Administrative Support:

    • Perform administrative tasks related to project activities, including keeping schedules up to date and managing project folders.


What We Expect from You:

Preferred Qualifications:

  • Strong analytical skills to solve day-to-day problems.

  • A methodical approach to completing tasks.

  • Solid written and oral communication skills.

  • Ability to communicate across various organizational levels and actively listen.

  • Ability to learn and adapt quickly to new systems, processes, and tools.

  • Organized, reliable, and responsive.

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.


What Amgen Offers:

Amgen is dedicated to supporting your professional and personal growth. With competitive benefits and a collaborative work culture, we provide the resources and opportunities for you to thrive. In addition to a competitive base salary, Amgen offers comprehensive Total Rewards Plans aligned with local industry standards.