Product Safety Specialist
New Jersey, NJ
Experience: 0
Category: Scientific & Clinical
Contractor Work Model: Remote
Brand: Joulé
Compensation Range: 45.00 - 48.00 Per Hour
Job ID: 346969
Date Posted: 04/07/2026
Shortcut: http://jobs.systemone.com/YsblWM
Job Title: Product Safety Specialist
Location: Remote
Type: 6 month contract
Compensation: $42-48/hour depending on qualifications (some flex for perfect fit)
Contractor Work Model: 100% Remote
Hours: Monday–Friday, 8:00 AM – 5:00 PM
Overview
This role supports pharmacovigilance activities by managing adverse event reporting and ensuring regulatory compliance for marketed and investigational products. You will apply clinical knowledge to evaluate safety data, interact with healthcare professionals and consumers, and maintain accurate case documentation within global safety systems.
Responsibilities
- Receive, document, and process adverse event and serious adverse event reports for domestic and international cases
- Conduct follow-up with healthcare professionals and consumers to obtain complete and medically relevant safety information
- Code and enter case data into the global safety database using MedDRA and internal coding standards
- Verify accuracy, completeness, and consistency of safety case records and supporting documentation
- Ensure timely submission of safety reports to regulatory authorities, partners, and affiliates in compliance with required timelines
- Provide product safety and medical information to healthcare professionals, consumers, and internal stakeholders
- Maintain working knowledge of product labeling, investigator brochures, and core data sheets to assess listedness and safety relevance
- Support audit readiness by maintaining compliant documentation and assisting with audit requests
- Participate in system validation activities and maintain proficiency in safety systems and workflows
- Identify and support process improvements to enhance safety reporting efficiency and compliance
Requirements
- Bachelor’s degree in a medical or health-related field with RN or RPh licensure, or PharmD/MD required
- 2–4 years of experience applying clinical medicine or pharmacy in an industry setting
- At least 1 year of experience in pharmaceutical drug safety or pharmacovigilance
- Experience interviewing healthcare professionals or consumers to collect medical or safety information
- Strong understanding of medical terminology, clinical care standards, and adverse event assessment
- Experience with safety databases and coding systems (e.g., MedDRA)
- Ability to manage case workloads independently while meeting strict regulatory timelines
- Proficiency with computer systems and data entry tools
Benefits
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #558-Scientific
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