Gpv Specialist - Hybrid

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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Gpv Specialist - Hybrid

Job Description

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