Employer Industry: Biotechnology and Pharmaceuticals

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 career advancement and growth within the organization
- Flexibility to work remotely or from the Durham, NC office with a hybrid schedule
- Chance to contribute to innovative solutions for unmet medical needs

What to Expect (Job Responsibilities):
- Provide strategic oversight of end-to-end case safety quality and ensure compliance in adverse effects reporting
- Drive process improvements and strengthen overall individual case safety report (ICSR) quality
- Implement proactive corrective/preventive actions to support safety surveillance and benefit-risk management
- Collaborate with vendors and partners to maintain high standards of quality and compliance
- Conduct retrospective reviews of case processing procedures

What is Required (Qualifications):
- Bachelor’s Degree in a related field such as chemistry or biology, or BSN, with 8+ years of experience in pharmacovigilance, OR
- Master’s Degree in a related field with 6+ years of experience in pharmacovigilance
- 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 for 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
- Familiarity with data entry processing, including QC, medical review, and regulatory submissions
- Prior experience in clinical or post-marketing environments

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