Intern-Medical Safety & Pharmacovigilance
Position Summary
The Intern-Medical Safety & Pharmacovigilance will support the Pharmacovigilance team in data collection and analysis for the preparation of Development Safety Update Reports (DSURs). This role involves scheduling meetings with cross-functional stakeholders, medical writing and scientific analysis of literature, archiving of documentation in the MSPV record-keeping system, and ensuring timely regulatory submission. Additionally, the intern will work closely with the Safety Physicians and Pharmacovigilance Operations and Compliance to support them in assisting in the completion of day-to-day responsibilities.
This intern will report to the Director of Benefit/Risk Assessment, based in Research Triangle Park, NC.
Job Responsibilities
- Support the preparation of Annual Safety Reports
- Learn pharmacovigilance processes, systems, and regulations
- Review the scientific literature
- Partner with cross-functional stakeholders to collect data
- Observe the clinical sub team meetings
- Participate in the planification of activities
- Assist the MSPV Operations and Compliance in the DSMB meetings preparation
Minimum Requirements
- Must be pursuing a Bachelor’s degree in the Life Sciences Field (Regulatory Affairs, Pharmacy, Biotechnology or related discipline)
- Must be at least a Senior in university at the time of your application
- Proficient with MS Office Suite and ability to learn new technologies quickly
- Excellent verbal and written communication skills
- Available to work full-time during the summer months (May-August)
- Proactive and solution-driven mindset
- Strong sense of accountability and ability to prioritize multiple tasks
- Excellent organizational skills and attention to detail
- Flexible and willing to support a variety of tasks for the Pharmacovigilance team
Preferred Education, Experience and Skills
- Students enrolled in a Master’s degree program in a related field encouraged to apply
- Prior internship, work, or volunteer/extracurricular experience
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