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    Drug Safety Associate

    Icon
    1+ years
    Not Disclosed
    India
    10 Dec. 17, 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 the Role:
    ICON plc, a leading global healthcare intelligence and clinical research organization, is seeking a Drug Safety Associate to join our dedicated team. As a Drug Safety Associate at ICON, you will be responsible for managing adverse event collection, processing, and reporting activities on behalf of the client’s Global Patient Safety Team. Your role will play an integral part in ensuring the quality and compliance of pharmacovigilance processes and regulatory requirements in clinical research.

    What You Will Be Doing:

    • Safety Management: Handle and enter Individual Case Safety Reports (ICSRs) from various sources and therapeutic areas.
    • Expedited Safety Reporting: Report expedited safety information to Regulatory Authorities (EMA, MHRA, HPRA).
    • Provide operational support to Country Affiliates for safety reporting activities.
    • Maintain and update EMA master data repositories.
    • Periodic Reporting: Prepare and maintain the periodic reporting calendar, distribute safety reports to global publishing teams, and track submissions to regulatory authorities.
    • Communicate effectively with internal and external stakeholders to ensure compliance with global procedures and quality systems.

    Your Profile:

    • Professional Competencies:
      • Effective communication skills (written and verbal) in a variety of settings.
      • Strong organizational and time management skills, with the ability to prioritize and meet deadlines.
      • Ability to build and maintain relationships within the functional area team and work collaboratively.
      • Demonstrated ability to receive and act upon feedback and provide constructive feedback.
      • Adhere to confidentiality guidelines and protect company information.
    • Minimum Requirements:
      • Effective communication skills, fluent in English.
      • Proficient in Microsoft Office Suite.
      • Knowledge of medical terminology and clinical industry processes.
      • Excellent organizational skills and attention to detail.
      • Ability to respond to requirements and requests promptly.
    • Preferred Requirements:
      • 1+ years of relevant experience in the clinical industry.
      • Knowledge of global pharmacovigilance regulations and medical coding systems.
      • Ability to work autonomously and adapt to changing priorities.
      • Demonstrated problem-solving and interpersonal skills.

    Benefits of Working at ICON:
    ICON is committed to fostering a continuous learning culture. We offer a competitive total reward package, including base pay, variable pay, and recognition programs. Our comprehensive employee benefits, supportive policies, and wellbeing initiatives are designed to support you and your family at all stages of your career.

    ICON is an equal opportunity and inclusive employer. We ensure a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

    If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please let us know.

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