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    Signal And Aggregate Report Specialist

    Arcolab Pvt Ltd
    2-5 years
    Preffered by Company
    Bangalore
    10 Aug. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

    Position: Signal and Aggregate Report Specialist
    Location: Bangalore (Work from Office)
    Experience Level: 2 to 5 Years
    Qualification: B.Pharm/M.Pharm

    Interested candidates, please send your resume to: Dev.kiran@arcolab.com

    Job Description:

    We are seeking experienced professionals to join our team as Signal and Aggregate Report Specialists. The ideal candidates will have a background in pharmacovigilance with experience in signal detection and aggregate reporting.

    Key Responsibilities:

    • Signal Report Authoring: Develop and author comprehensive signal detection reports for medicinal products, utilizing statistical and data mining techniques to uncover trends and potential safety issues.
    • Aggregate Report Preparation: Draft and prepare aggregate reports in accordance with regulatory requirements and industry standards.
    • Data Management: Generate and review line-listings from safety databases, and ensure accurate representation of data.
    • Literature Review: Conduct thorough reviews of scientific literature and health authority websites to gather and integrate new safety information.

    Collaboration and Communication:

    • Cross-Functional Coordination: Work closely with pharmacovigilance, medical affairs, regulatory affairs, and quality assurance teams to ensure cohesive and effective reporting.
    • Stakeholder Communication: Maintain proactive communication with internal stakeholders to resolve issues promptly and align on priorities.
    • External Liaison: Interface with external partners, including regulatory agencies, vendors, and healthcare professionals, as required.

    If you are passionate about pharmacovigilance and have the necessary experience, we invite you to apply and become a key part of our dynamic team.

    To Apply:

    Please submit your resume to Dev.kiran@arcolab.com with the subject line "Signal and Aggregate Report Specialist Application".

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