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    Safety Writer - Aggregate Reporting

    Advity Research
    3-5 years
    upto 9 LPA
    Hyderabad
    5 Aug. 7, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D 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

    Job Title: Safety Writer – Aggregate Reporting (AR)

    Location: Hyderabad

    Experience Required: 3 to 5 years

    Employment Type: Full Time

    Department: Pharmacovigilance

    Qualification:

    • Graduate/Post Graduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or equivalent degree.
    • Fluency in English.

    Mode of Work: On premise

    Job Description:

    • Primary Contact and Expert: Serve as Advity’s primary contact and expert for aggregate reports.
    • Effective Communication: Interact and communicate effectively internally and cross-functionally in a highly matrixed environment.
    • Safety Data Analysis: Draft, retrieve, and analyze safety data from the global safety database and ensure adequate presentation in ARs (PADER/PSUR/PEBRER/RMP/DSUR/ADco’s).
    • Aggregate Analysis: Ensure a comprehensive and consistent aggregate analysis to establish the risk-benefit profile of the product that meets all Health Authority (HA) requirements.
    • Safety Issues Alert: Alert Medical Safety Physicians of potential safety issues and assist them in monitoring the safety profile of products.
    • Quality Control: Support independent QC of ARs to ensure the information presented is complete, consistent, and compliant with regulatory and Advity standards. Adhere to good documentation practices to ensure audit/inspection readiness.
    • Operational Excellence Projects: Support projects related to operational excellence, including testing of safety systems/IT applications, and process improvements according to internal and external drivers.
    • Literature Review: Review literature articles to identify case safety reports.
    • Pharmacovigilance Activities: Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
    • Signal Generation and Safety Analysis: Assist in signal generation and safety analysis activities.
    • Inspections and Audits Support: Support Health Authority inspections and audits, and develop Corrective & Preventative Actions (CAPA) to address safety findings.
    • Regulatory Awareness: Stay informed with the current global PV regulatory requirements.

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