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    Pharmacovigilance Associate

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    1+ years
    Not Disclosed
    Seoul
    10 Nov. 8, 2024
    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

    About ICON plc

    ICON plc is the world’s largest and most comprehensive clinical research organization, driven by healthcare intelligence. We are committed to fostering an inclusive environment where innovation and excellence thrive. As part of our mission to advance healthcare outcomes, we invite you to join us in shaping the future of clinical development.

    Role Overview

    As a Pharmacovigilance Associate, you will play a vital role in ensuring the safety of healthcare products in the Korean market. You will manage the collection, documentation, and transmission of pharmacovigilance (PV) cases, ensuring compliance with local regulations and internal procedures. You will also collaborate with internal teams and external authorities to ensure the highest standards of safety reporting.

    Key Responsibilities

    • Safety Reporting:

      • Ensure submission of expedited and periodic safety reports to Regulatory Authorities in Korea, in compliance with local regulations, for both clinical trials and post-marketing activities.
      • Manage collection, processing, follow-up, transmission, and documentation of post-marketing PV cases (e.g., spontaneous reports, literature, post-marketing studies).
      • Handle health authority cases for product renewals and ensure timely case entry into safety databases.
      • Conduct local literature reviews on a weekly basis to detect adverse events (AEs) and ensure timely reporting per internal procedures.

    • Compliance & Monitoring:

      • Monitor PV activities to ensure compliance with company procedures, local regulations, and timelines.
      • Implement Corrective and Preventive Actions (CAPA) when required to address non-compliance or issues within the process.
      • Perform monthly reconciliations with other functions (e.g., quality complaints, medical information inquiries) to ensure all potential AEs are identified and reported.

    • Collaboration & Reporting:

      • Reconcile local PV cases with Global Safety to ensure accurate case collection and entry into the global safety database.
      • Collaborate with other departments involved in Risk Management Plans (RMP) activities and ensure successful implementation within Korea.
      • Assist in the implementation of RMP activities and coordinate with stakeholders as needed.

    • Filing & Documentation:

      • Ensure proper tracking, filing, and archiving of PV documentation in accordance with internal processes.
      • Maintain readiness of project files for audits and inspections.

    • Additional Responsibilities:

      • Support other tasks as assigned by management, ensuring smooth execution of safety reporting activities.

    What You’ll Bring

    • Experience: A minimum of 1.5 years of experience in pharmacovigilance, within a CRO or pharmaceutical industry.
    • Skills: Proficient in English, with strong communication skills.
    • Education: Degree in a related field (e.g., life sciences, pharmacy, etc.).
    • Ability to work office-based, with some flexibility for home-based work.

    What ICON Can Offer You

    At ICON, our success is built on the strength of our people. In addition to a competitive salary, we offer a variety of benefits focused on your well-being and work-life balance, including:

    • Annual leave entitlements and health insurance options to suit you and your family’s needs.
    • Retirement planning offerings for long-term financial security.
    • Access to our Global Employee Assistance Program (TELUS Health), providing 24/7 support for personal and family well-being.
    • Life assurance and a range of flexible, country-specific benefits, including childcare vouchers, gym memberships, subsidized travel passes, and more.

    Diversity & Inclusion at ICON

    At ICON, diversity, inclusion, and belonging are integral to our culture and values. We believe that a diverse workforce makes us more innovative and enables us to better serve our people, patients, clients, and communities. We are committed to providing an inclusive and accessible environment for all candidates.

    ICON is an equal opportunity employer and provides equal consideration for employment to all qualified applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    Interested? Apply Today!

    We encourage you to apply even if you don’t meet every single requirement – there’s a strong chance you’re exactly what we’re looking for!
    [Apply Here] (Insert application link)

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    Warsaw |

    Remote :

    Bountiful | Minnesota | French | Hammond | McFarland | Slovakia | Thailand | Castlebar | Remote - Middle East | Xzagreb | Melbourne | Remote, USA | Remote - South America (Latin Americal) | Nairobi | Lenexa | Remote - Africa | Switzerland | Medan | Green Way | Tulsa | Riga | Zaragoza | Remote | Victoria | Hungary | Leinster | Texas | Blue Bell | Belgium | Springville | Remote - Europe | Ireland | Faridabad | Manipal | Lousiana | Bishop |

    Bucharest :

    Bucharest |

    Makkah :

    Khulais | Jeddah | Rabigh | King Abdullah Economic City | Najran | Riyadh |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Peru | Argentina |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |