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    Safety Systems Analyst Ii (Pharmacovigilance)

    Aequor
    4+ years
    Not Disclosed
    Princeton Junction
    12 June 10, 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

    Position: Safety Systems Analyst II

    Employer: Aequor

    Category: Safety

    Location:

    • Country: United States
    • State: New Jersey (NJ)
    • City: Princeton

    Job Code: 24-01643

    Post Date: 06/06/2024

    Description:

    Job Title: Safety Systems Analyst II

    Scope of Role: Responsible for supporting the maintenance of the Pharmacovigilance (PV) database and performing PV database data retrieval activities.

    Primary Responsibilities:

    • Execute weekly, monthly, and ad hoc reports from the PV database.
    • Perform all required Quality Control (QC) and complete documentation.
    • Assist with the execution and verification of Ethics Committee and Health Authority Periodic outputs.
    • Maintain and distribute the Study Configuration Spreadsheet.
    • Maintain and distribute applicable sections of the Data Entry Conventions and associated appendices.
    • Track the development, testing, implementation, and closure of all PV Systems requests.
    • Assist PV Systems Director with various activities related to maintaining and delivering systems supporting the PV business unit, with a primary focus on the Argus Safety Systems.
    • Monitor PV System vendor activities and ensure compliance with contractual expectations.
    • Maintain documentation of system configuration and all subsequent changes.
    • Validate and implement annual, periodic, and ad-hoc reports in the Drug Safety systems.
    • Maintain processes for systems in compliance with regulatory requirements and company standards.

    Skills:

    Education/Experience/Skills:

    • At least 4 years of experience in Pharmacovigilance Systems with at least 2 years of experience with data retrieval from the Oracle Argus Safety Database.
    • Attention to detail, critical thinking, creative problem-solving, collaborative approach.
    • Proficient Computer Skills, including Microsoft Word and Excel.
    • Knowledge of Drug Safety and Pharmacovigilance function.
    • Fluent in English (verbal and written).

    Keywords:

    • Problem-Solving
    • Drug Safety
    • Database
    • Pharmacovigilance
    • Excel

    Languages:

    • English: Read, Write, Speak

    Minimum Degree Required: Completed High School (Diploma or GED)

     

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