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Quality Specialist - Pharmacovigilance (Remote)

2+ years
$47.56 per hour
10 Oct. 22, 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

Pharmacovigilance Compliance Specialist

Location: Remote

Job Description

Under the guidance of the PV Quality and Compliance Associate Director, the Pharmacovigilance Compliance Specialist will:

  • Review individual case safety report compliance monitoring outputs to ensure high-quality reporting in line with PV regulations and business partner agreements.

  • Assist in developing and implementing processes to monitor the compliance of individual case safety reports.

  • Participate in special projects focused on compliance monitoring to ensure data quality.

Education and Experience

  • Bachelor's or Master's degree in life sciences with a minimum of 4-5 years of relevant experience in pharmacovigilance investigations or deviation management.

  • Strong analytical skills with a focus on quality.

  • Knowledge of pharmacovigilance principles, systems, and regulations.

  • Experience with pharmacovigilance investigations or deviation management.

Software Expertise

  • Proficient in Office 365 applications.

  • Experience with safety databases, preferably ARGUS (similar software experience will be considered).

Additional Information

  • This is a 3-month assignment with the possibility of extension.

  • 100% remote role.

  • Candidates must have access to their own laptop or desktop to perform the work.

Equal Employment Opportunity

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.