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Gpv Specialist - Hybrid

7-10 years
$50000/yr - $55000/yr
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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