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Pharmacovigilance Reporting Associate

2+ years
Not Disclosed
10 May 17, 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

Pharmacovigilance Reporting Associate
Location: Seoul
Job Reference: JR130553
Department: Drug Safety – ICON Full Service & Corporate Support (Office Based)

About ICON:
ICON plc is a global leader in healthcare intelligence and clinical research. We are committed to innovation, inclusion, and excellence in advancing clinical development. At ICON, people are our greatest asset, and we foster a collaborative and supportive environment to empower individuals in shaping a better future for patients worldwide.

Position Overview:
As a Pharmacovigilance Reporting Associate, you will play a critical role in the preparation and submission of accurate and timely safety reports associated with clinical trials and post-marketing activities. You will ensure strict compliance with applicable regulatory requirements and contribute to robust safety data management processes that support patient safety and organizational integrity.

Key Responsibilities:

  • Prepare and review safety reports, including Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs), ensuring compliance with applicable regulations.

  • Collect, compile, and analyze adverse event data from various sources including clinical trials and post-marketing reports.

  • Stay updated on evolving regulatory requirements and global pharmacovigilance reporting standards.

  • Collaborate closely with internal teams across clinical operations, regulatory affairs, and data management to support seamless data flow and report generation.

  • Ensure punctual submission of safety documentation to relevant regulatory authorities and study sponsors, maintaining adherence to all applicable timelines and standards.

Candidate Profile:

  • Bachelor’s degree in Life Sciences, Pharmacy, or related discipline.

  • Prior experience in pharmacovigilance or drug safety, with sound knowledge of safety data handling and reporting processes.

  • High attention to detail and exceptional organizational skills to manage and review complex documentation.

  • Strong verbal and written communication skills with the ability to work effectively in a team-oriented environment.

  • Capability to manage multiple priorities and meet deadlines in a regulatory-driven work setting.

Why Join ICON?

  • Competitive salary structure with performance-based annual bonuses.

  • Comprehensive health insurance tailored to you and your family’s needs.

  • Retirement planning programs to help secure your future.

  • Access to ICON’s Global Employee Assistance Programme (LifeWorks) providing 24/7 support across mental, financial, and physical wellness.

  • Additional country-specific benefits including subsidized gym memberships, travel passes, health assessments, and more.

Diversity & Inclusion:
ICON is an equal opportunity employer dedicated to fostering a diverse and inclusive workplace. All qualified applicants will receive fair consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If accommodations are required due to a medical condition or disability during the hiring process or in performing the role, please inform us.

Note: Even if you don’t meet every requirement, we still encourage you to apply — your unique background could be exactly what we need.