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Bengaluru

    Associate Lead - Bengaluru, India - Arcolab Private Limited

    Arcolab Private Limited
    Arcolab Private Limited Bengaluru, India

    3 hours ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Qualification: MBBS/MD (only from Indian university)

    Experience: 2 to 4 years

    • Previous experience in medical review of ICSRs, Signal detection activity and aggregate safety reports.
    • Knowledge of safety databases, such as Argus, ARISg, or similar systems.
    • Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B).
    • Strong attention to detail and ability to work with complex medical data.
    • Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.

    Key Responsibilities:

    Individual Case Safety Reports (ICSRs) Review:

    • Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature.
    • Assess the medical relevance and causality of adverse events reported in ICSRs.
    • Identify and evaluate potential safety signals and perform appropriate follow-up actions as necessary.
    • Ensure accurate and timely reporting of serious and non-serious adverse events to regulatory authorities.

    Aggregate and Signal Reports:

    • Review and evaluate aggregate safety reports, such as periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), development safety update reports (DSURs), CAR, and PADERs.
    • Review and evaluate Signal detection reports and RMPs.
    • Ensure compliance with regulatory guidelines and reporting requirements during the review of aggregate reports.
    • Identify any emerging safety concerns, trends, or patterns from the aggregated safety data.
    • Collaborate with cross-functional teams to contribute to risk management activities and safety signal detection.
    • Authoring/review of signal detection activity
    • Utilize statistical and data mining techniques to identify trends and patterns indicative of potential safety concerns. Performing validation for potential signals.
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