Pharmacovigilance Associate

Job Summary

To support pharmacovigilance operations, the full-time remote Pharmacovigilance Associate will manage adverse event reporting, collaborate with internal and external stakeholders, and ensure compliance with regulatory requirements for investigational products.

Key Responsibilities:

• Serve as the main point of contact for adverse event inquiries and reviews within safety and clinical databases
• Conduct initial reviews of SAE/AESI reports and perform quality control checks in the Argus database
• Assist in the preparation of safety reports for regulatory agencies and maintain documentation within the eTMF

Required Qualifications:

• Bachelor's degree or higher in a clinical or closely related field
• 2-3 years of relevant experience in a biotech or pharmaceutical company
• 1-2 years of experience in cellular therapy, stem cell transplant, and/or oncology preferred
• Proficiency in the Argus safety database system
• Working knowledge of MedDRA and WHODrug coding preferred