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    Jr Drug Safety Associate Ii - Signal Management

    Vizen Life Sciences
    1-3 years
    Not Disclosed
    India
    10 July 26, 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, 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

    Job Title: Safety Signal Detection Specialist

    Key Responsibilities:

    • Safety Signal Detection and Triage:

      • Conduct safety signal detection and triage activities for a diverse and complex product portfolio.
      • Identify new safety signals through detailed medical evaluation of technical alerts from post-marketing spontaneous reporting databases and aggregate data analysis.

    • Expert Evaluation:

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

    • Collaboration:

      • Collaborate effectively with safety leads for respective products.
      • Serve as a core member of the Signal Management Team, offering expert input on post-marketing signal detection using both internal and external spontaneous reporting databases.

    • Database Searches and Analysis:

      • Conduct database searches in external Health Authority databases (FAERS, Vigibase, iDAP, DAEN) and analyze the results.
      • Perform quality control (QC) checks of database searches conducted by colleagues.

    • EudraVigilance Management:

      • Manage requests and monitor the EudraVigilance database for assigned products.
      • Support and mentor junior Safety Signal colleagues.

    • Development of Guidance Documents:

      • Lead the development and revision 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:

    • Bachelor’s degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences); advanced degree preferred.
    • Extensive experience in pharmacovigilance, drug safety, or a related field, with a focus on safety signal detection and triage.
    • In-depth knowledge of post-marketing spontaneous reporting databases and Health Authority databases (FAERS, Vigibase, iDAP, DAEN).
    • Strong analytical and problem-solving skills with the ability to interpret complex safety data.
    • Proven ability to collaborate effectively with cross-functional teams and provide expert input in a matrix environment.
    • Experience in managing EudraVigilance database requests and performing QC checks on database searches.
    • Strong organizational skills with the ability to manage multiple tasks and projects simultaneously.
    • Excellent written and verbal communication skills.
    • Proficiency in developing and updating SOPs and Business Guidance documents.

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