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Senior Pharmacovigilance Reporting Associate

3-5 years
Not Disclosed
10 June 5, 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

 

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Senior Pharmacovigilance Reporting Associate Job in Seoul | ICON

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Apply for Senior Pharmacovigilance Reporting Associate in Seoul. Join ICON to advance your drug safety career with competitive benefits and flexible work options.

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Senior Pharmacovigilance Reporting Associate – Seoul, Korea (Office with Flex)

Job Summary

Join ICON, a global leader in healthcare intelligence and clinical research, as a Senior Pharmacovigilance Reporting Associate in Seoul. In this critical role, you will ensure timely, accurate safety data reporting to support drug safety compliance and protect patient health. This opportunity is ideal for professionals with a strong background in pharmacovigilance, drug safety reporting, and regulatory compliance looking to thrive in a dynamic, fast-paced pharmaceutical environment.


Key Responsibilities

  • Prepare and submit adverse event reports and safety data adhering to regulatory standards and internal policies.

  • Collaborate with clinical and regulatory teams to review safety data, identify trends, and investigate potential safety signals.

  • Assist in compiling Periodic Safety Update Reports (PSURs), annual reports, and other regulatory documentation.

  • Monitor timelines for safety report submissions and proactively address any delays or issues.

  • Maintain and update pharmacovigilance databases, ensuring high-quality and validated safety data.

  • Train and support junior staff on pharmacovigilance reporting procedures and regulatory requirements.

  • Participate in regulatory audits and inspections, ensuring readiness and compliance.

  • Stay current on regulatory guidelines and industry best practices to continuously improve pharmacovigilance reporting.


Required Skills & Qualifications

  • Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree preferred.

  • Extensive experience in pharmacovigilance or drug safety reporting within pharmaceutical or clinical research environments.

  • In-depth knowledge of pharmacovigilance regulations and reporting guidelines (ICH-GVP, FDA, EMA).

  • Proven ability to accurately prepare and submit adverse event reports in a timely manner.

  • Strong analytical skills to interpret safety data and detect safety signals.

  • Proficient with pharmacovigilance databases, reporting tools, and Microsoft Office Suite.

  • Excellent communication and teamwork skills with the ability to collaborate cross-functionally.

  • Strong organizational skills to handle multiple projects in a fast-paced setting.

  • Commitment to confidentiality and ethical handling of sensitive patient data.


Perks & Benefits

  • Competitive salary (salary range not specified).

  • Flexible work environment with office-based and flexible work options.

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

  • Various annual leave entitlements promoting work-life balance.

  • Competitive retirement planning and savings schemes.

  • Access to Global Employee Assistance Programme (LifeWorks) for personal and family support.

  • Life assurance and wellness programs including gym memberships, travel subsidies, and more.

  • Inclusive workplace committed to diversity, equity, and accessibility.


About ICON plc

ICON plc is a world-leading clinical research and healthcare intelligence organization focused on innovation and excellence. With a global presence, ICON fosters a collaborative and inclusive environment, advancing clinical development and drug safety to improve patient outcomes worldwide.


Work Mode

Hybrid – Office-based in Seoul with flexible working options.


Call to Action

Ready to advance your pharmacovigilance career with ICON in Seoul? Apply now to join a global leader dedicated to clinical excellence and patient safety. Don’t miss your chance—submit your application today!