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Associate Is - Safety Art - Icsr Processing - Icma

4-7 years
Not Disclosed
10 March 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Associate IS - Safety ART - ICSR Processing - ICMA

Location: Hyderabad, India
Job Type: Full-Time (On-Site)
Experience: 0-3 Years

About Amgen:

Amgen is a global biotechnology company committed to serving patients with serious illnesses. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, Amgen pioneers innovative medicines that help millions live longer, fuller, and happier lives.

Job Responsibilities:

  • Monitor and resolve daily data processing issues related to adverse events across multiple systems.
  • Identify and resolve data reconciliation issues, working with cross-functional teams.
  • Collaborate with internal and external teams to manage system dependencies and address bottlenecks.
  • Maintain records of recurring issues, fixes, and preventive measures to improve process efficiency.
  • Develop dashboards and reports to track system performance and file flow metrics.
  • Participate in team meetings to discuss insights and process improvements.
  • Ensure data compliance with KCI metrics on a regular basis.
  • Develop and execute test plans and scripts to validate system updates and patches.
  • Document and report system bugs to developers or vendors for resolution.
  • Conduct regression testing to ensure updates do not impact existing functionalities.
  • Automate repetitive testing processes for efficiency.

Qualifications:

Basic Requirements:

  • Bachelor’s degree with 0-3 years of experience in Life Science, Biotechnology, Pharmacology, or Information Systems
    OR
  • Diploma with 4-7 years of experience in the same fields.

Must-Have Skills:

  • Strong analytical and problem-solving skills.
  • Experience with data transfer processes and troubleshooting issues.
  • Knowledge of testing methodologies and quality assurance standards.
  • Proficiency in data analysis and QA tools.
  • SQL knowledge is helpful.

Good-to-Have Skills:

  • Experience with Oracle SQL, PL/SQL.
  • Familiarity with API integrations (e.g., MuleSoft).
  • Strong communication skills to explain technical concepts to non-technical teams.
  • Knowledge of SDLC, reporting tools (e.g., Tableau).
  • SAFe for Teams certification (preferred).

Soft Skills:

  • Ability to work independently with minimal supervision.
  • Strong mentorship and delegation skills.
  • Excellent verbal and written communication.
  • Ability to manage multiple priorities successfully.
  • Team-oriented with a goal-driven mindset.

Shift Information:

  • Candidates must be willing to work evening or night shifts as required.