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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 (Possibility of Extension)
Company: Nesco Resource


Job Overview

Under the guidance of the PV Quality and Compliance Associate Director, the Pharmacovigilance (PV) Compliance & Quality Specialist will be responsible for ensuring high-quality and compliant reporting of individual case safety reports (ICSRs) in accordance with PV regulations and business partner agreements. This role involves conducting regular reviews of safety data, assisting in the development of monitoring processes, and participating in special compliance projects as necessary to ensure optimal data quality.


Key Responsibilities

  • Compliance Monitoring: Review individual case safety reports (ICSRs) to ensure adherence to regulatory requirements and company standards.
  • Process Development: Assist in the creation and implementation of processes for ongoing monitoring of ICSR compliance.
  • Special Projects: Participate in special compliance monitoring initiatives aimed at improving data quality within PV operations.

Qualifications

Education & Experience:

  • Bachelor’s or Master’s degree in a life science field.
  • 4-5 years of relevant experience in Pharmacovigilance, specifically within investigations or deviation management.

Skills & Knowledge:

  • Strong analytical skills and a keen focus on quality assurance.
  • In-depth knowledge of Pharmacovigilance principles, systems, and regulations.
  • Experience with Pharmacovigilance investigations or managing deviations.

Software Expertise:

  • Proficiency in Office 365 applications.
  • Experience with safety databases (preferably ARGUS or similar software platforms).

Additional Information

  • Remote Role: This is a 100% remote position.
  • Technology Requirements: Candidates should have access to their own laptop or desktop to perform the role.

Equal Opportunity Employer

Nesco Resource is an equal employment opportunity employer. We are committed to providing a work environment free from discrimination and harassment of any kind, based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other characteristic protected by federal, state, or local laws.