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    Jr Drug Safety Associate Ii - Signal Management

    Vizen Life Sciences
    1-3 years
    Not Disclosed
    Remote
    10 Aug. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

    Key Responsibilities:

    1. Safety Signal Detection and Triage:

      • Conduct safety signal detection and triage for a complex portfolio of products.
      • Identify new safety signals through comprehensive medical evaluation of technical hits in post-marketing spontaneous reporting databases and aggregate data analysis.

    2. Expert Evaluation:

      • Provide expert analysis of post-marketing signal detection results during cross-functional team meetings, such as Safety Review Meetings and Joint Safety Committees.

    3. Collaboration:

      • Work closely with safety leads for respective products.
      • Act as a core member of the Signal Management Team, offering expert insights on post-marketing signal detection using both internal and external reporting databases.

    4. Database Searches and Analysis:

      • Perform searches in external Health Authority databases (e.g., FAERS, Vigibase, iDAP, DAEN), analyze, and report findings.
      • Conduct quality control checks on database searches performed by colleagues.

    5. EudraVigilance Management:

      • Oversee EudraVigilance database requests and monitor the database for assigned products.
      • Provide training and mentorship to junior Safety Signal Colleagues.

    6. Development of Guidance Documents:

      • Lead the development and updating of Business Guidance documents and Standard Operating Procedures (SOPs).
      • Contribute to the creation of new approaches for automated signal detection in both internal and external databases.

    Qualifications:

    • Education: Bachelor’s degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences). An advanced degree is preferred.
    • Experience: Proven experience in pharmacovigilance or drug safety with a focus on safety signal detection and triage.
    • Technical Knowledge: Familiarity with post-marketing spontaneous reporting databases and Health Authority databases (FAERS, Vigibase, iDAP, DAEN).
    • Skills: Strong analytical and problem-solving abilities with a capacity to evaluate and interpret complex safety data.
    • Collaboration: Demonstrated ability to work effectively with cross-functional teams and provide expert input in a matrix environment.
    • Database Management: Experience managing EudraVigilance database requests and conducting quality checks on database searches.
    • Organizational Skills: Ability to manage multiple tasks and projects simultaneously with strong organizational skills.
    • Communication: Excellent written and verbal communication skills.
    • Documentation: Proficiency in developing and updating SOPs and Business Guidance documents.

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