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    Gpv Specialist - Hybrid

    Gforce Life Sciences
    7-10 years
    $50000/yr - $55000/yr
    Princeton Junction
    10 May 17, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Opportunity: GPV Submission Specialist

    Company: GForce Life Sciences

    Client: Mid-sized pharmaceutical company

    Summary: GForce Life Sciences is seeking a GPV Submission Specialist to manage the daily operational activities of the Global Submissions Team within Case Processing for a growing, mid-sized pharmaceutical client.

    Description:

    Key Responsibilities:

    • Monitor and manage ICSR workflow for assigned projects and products to ensure deadlines are met and compliant with safety reporting obligations.
    • Support PV Management in overseeing Case Management vendors, including triage, troubleshooting, and escalation.
    • Collect, document, and process adverse event (AE) reports from clinical trials and post-marketing sources.
    • Supervise follow-up activities with consumers and healthcare professionals.
    • Serve as a Subject Matter Expert (SME) for MedDRA coding and ICSR handling during PV-related regulatory inspections or internal audits.
    • Manage and oversee PV vendor(s) and coordinate with external pharmacovigilance providers (CROs) and Business Partners.
    • Support PV management in CAPA-related activities and investigations.
    • Participate in training related to Case Management.
    • Assist the Clinical Research Department as an SME for case processing.
    • Adhere to GCP guidelines and regulatory reporting regulations.
    • Generate database queries for AE listings.
    • Participate in User Acceptance Testing for Case Management Initiatives.
    • Perform end-to-end case processing, including triage, data entry, assessment, quality review, query generation, and MedDRA coding.
    • Support the development and updates of guidance documents, including PVAs, SMPs, SOPs.
    • Provide safety operations support for assigned studies.
    • Support PV inspection/audit activities and Health Authority requests.

    Qualifications/Experience:

    • Bachelor's degree in Science or a related healthcare field preferred.
    • 7-10 years of progressive pharmacovigilance experience required.

    Required Skills:

    • Knowledge of global safety reporting regulations and guidelines, including FDA, ICH, and EU regulations.
    • Experience with the ARGUS Safety Database.
    • Prior experience in case processing and expedited ICSR submissions to Health Authorities.
    • Knowledge of medical device submissions and ICSR submissions to Ethics Committees and Investigators.
    • Product configuration management and signal detection management experience.

    Terms & Start:

    • Contract Duration: 12 months, with the possibility of a 12+ month extension.
    • Interviews: 2 video interviews.
    • Start Date: 2-3 weeks from offer.
    • Work Schedule: Full-time, 40 hours/week.
    • Location: Hybrid - onsite 2 days a week.
    • Benefits: Medical, Dental, Vision, 401k.

    To Apply: Visit www.careers.indegene.com for more information and application details.

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