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    Pv Specialist

    Pharmalex
    1+ years
    Not Disclosed
    Noida
    10 Oct. 29, 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, 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

    Your Job:
    As a PV Specialist, you will be integral to our pharmacovigilance efforts, handling key tasks such as:

    • Data Entry: Accurately input data into the PV database.
    • Initial Assessment: Perform initial assessments of Individual Case Safety Reports (ICSRs), as applicable.
    • Expedited Reporting Evaluation: Evaluate the necessity for expedited reporting to Health Authorities or client partners, including adherence to reporting timelines.
    • Reporting Preparation: Prepare standard reporting forms (e.g., CIOMS I, MedWatch Forms, and XML files) for submission.
    • Follow-Up Requests: Prepare and send follow-up requests to obtain additional information as necessary.
    • ICSR Submission: Submit ICSRs to Health Authorities and client partners, ensuring compliance with regulatory requirements.
    • Case Completion: Ensure thorough documentation and completion of cases.
    • Quality Check: Conduct quality checks on ICSRs to maintain data integrity.
    • Search/Retrieval: Perform the ICSR search and retrieval process from the EVWEB database and assess cases from both company and non-company sources.
    • Case Management: Allocate and manage cases effectively within the team.
    • Training: Provide training on the system to team members to enhance their operational capabilities.
    • Additional Responsibilities: Undertake other tasks as assigned by the Management team.

    Your Profile:

    • Experience: Minimum 1 year of case processing experience.
    • Software Knowledge: Proficient in ARGUS and ARISG.
    • Qualification: B.Pharm, BDS, Pharm D, or M.Pharm.
    • Communication Skills: Excellent verbal and written communication skills.
    • Work Environment: Willingness to work from the office in Noida.

    If you're interested in joining our Pharmalex team for this exciting opportunity in a dynamic company, we look forward to receiving your application, including your earliest possible start date, any visa requirements, and salary expectations.

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