United Therapeutics
Lead Pharmacovigilance QC Specialist
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Job Description
- Req#: R04086
Employer Industry: Biotechnology and Pharmaceutical
Why consider this job opportunity:
- Salary up to $165,000 per year
- Eligible for short-term and long-term incentive programs
- Comprehensive benefits suite including medical, dental, vision, and prescription coverage
- Opportunity for remote work or a hybrid schedule in Durham, NC
- Engage in innovative projects that aim to address critical medical needs
- Join a company dedicated to developing novel therapies and technologies for patients
What to Expect (Job Responsibilities):
- Provide strategic oversight of end-to-end case safety quality, ensuring compliance and quality in adverse effects and reporting
- Drive process improvements to strengthen overall individual case safety report (ICSR) quality
- Collaborate with vendors and partners to ensure adherence to quality standards and case processing procedures
- Implement proactive corrective and preventive actions to support safety surveillance and benefit-risk management
- Conduct retrospective reviews of ICSR processes and reporting
What is Required (Qualifications):
- Bachelor’s Degree in a related field such as chemistry or biology, or BSN, with 8+ years of pharmacovigilance experience, OR
- Master’s Degree in a related field with 6+ years of pharmacovigilance experience
- 3+ years of experience in vendor management and oversight
- Previous experience using Argus or other safety databases
- Strong knowledge of case processing and quality assurance in clinical trial cases and post-marketing reports
How to Stand Out (Preferred Qualifications):
- Master’s degree in a related field such as chemistry or biology
- 2+ years of experience in clinical trial or product development
- Knowledge of data entry processing from start to finish (QC, medical review, regulatory submissions)
- Prior clinical or post-marketing experience
#Biotechnology #Pharmaceuticals #Pharmacovigilance #RemoteWork #CareerOpportunity
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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.About the company
United Therapeutics is a biotechnology company listed on the NASDAQ.
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