Quality Specialist Ii - 100% Remote - Pharmacovigilance Compliance

On-Board Companies

2+ years

$48 per hour

Remote

10 Sept. 19, 2024

Job Description

Job Type: Remote 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: Quality Specialist II – Pharmacovigilance Compliance
Location: 100% Remote
Contract Duration: 1 year (with potential for extension based on performance and business needs)
Compensation: $48 per hour

About Us:

On-Board Services, Incorporated is a contract service provider delivering full-time positions to our employees. We offer comprehensive benefits, including a 401k plan.

Position Overview:

We are seeking a Quality Specialist II in Pharmacovigilance Compliance to join our client, Organon. This role is vital for ensuring high-quality and compliant reporting in accordance with pharmacovigilance regulations.

Responsibilities:

Review individual case safety report compliance monitoring outputs to maintain high standards of quality and compliance.
Assist in developing and implementing processes for monitoring the compliance of individual case safety reports.
Participate in compliance monitoring special projects to ensure data quality.

Qualifications:

Bachelor's or Master’s degree in Life Sciences.
4-5 years of relevant experience in pharmacovigilance, including investigations and deviation management.
Strong analytical skills with a focus on quality.
In-depth knowledge of pharmacovigilance principles, systems, and regulations.
Proficient in Office 365 applications.
Experience with safety databases, preferably ARGUS, or similar software.

Additional Information:

Must have a personal laptop or desktop to perform the work.
This position starts as a 3-month contract, with a strong possibility of extension.

How to Apply:

For immediate consideration, please send your resume to resumes@onboardusa.com with the subject line: “Quality Specialist II and Your State.”

About On-Board:

Founded in 1976, On-Board has grown into a diverse family of companies offering consulting, professional engineering, industrial maintenance, and staffing services across North America. Our mission is to deliver flexible service through our talented workforce while ensuring safety and responsibility.

Equal Employment Opportunity: On-Board Companies is committed to providing equal employment opportunities to all employees and applicants without regard to race, religion, sex, national origin, age, disability, or genetics.

Job Code: JD# 24-02378
Tag: INDOJ

Apply Today! www.onboardusa.com

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Quality Specialist Ii - 100% Remote - Pharmacovigilance Compliance

Job Description

About Us:

Position Overview:

Responsibilities:

Qualifications:

Additional Information:

How to Apply:

About On-Board:

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