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Quality Specialist - Pharmacovigilance (Remote)

2+ years
Not Disclosed
10 Nov. 5, 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

Job Title: Pharmacovigilance (PV) Compliance & Quality Specialist
Location: Remote
Duration: 3-Month Assignment (Possible Extension)
Company: Nesco Resource


Job Overview

Under the supervision of the PV Quality and Compliance Associate Director, the Pharmacovigilance Compliance & Quality Specialist will be responsible for reviewing individual case safety reports (ICSRs) to ensure adherence to Pharmacovigilance (PV) regulations and business partner agreements. This position also involves supporting the development and implementation of monitoring processes for compliance and participating in special projects to enhance data quality in PV operations.


Key Responsibilities

  • Compliance Monitoring: Perform reviews of ICSR compliance outputs to ensure high-quality and compliant reporting.
  • Process Development: Assist in the creation and implementation of processes for monitoring the compliance of individual case safety reports.
  • Special Projects: Participate in compliance monitoring initiatives to support the maintenance of high-quality PV data.

Qualifications

Education & Experience:

  • Bachelor's or Master's degree in a life science field.
  • 4-5 years of relevant experience in Pharmacovigilance, particularly with investigation or deviation management.

Skills & Knowledge:

  • Strong analytical skills and an emphasis on quality assurance.
  • Solid understanding of Pharmacovigilance principles, systems, and regulations.
  • Experience with Pharmacovigilance investigations or managing deviation processes.

Software Expertise:

  • Proficient in Office 365 applications.
  • Experience with safety databases (preferably ARGUS, or similar).

Additional Information

  • Remote Position: This is a fully remote opportunity.
  • Technology Requirements: Candidates must have their own laptop or desktop to perform the tasks.

Equal Opportunity Employer

Nesco Resource is committed to providing equal employment opportunities to all individuals, regardless of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other characteristic protected by applicable laws.