Pharmacovigilance Associate - Remote Position
About this role
About the Role
Pharmacovigilance Associate will support safety monitoring and regulatory compliance for Puma Biotechnology's portfolio. This remote role focuses on pharmacovigilance processes, data integrity, and collaboration with cross-functional teams to maintain safety standards.
What You'll Do
- Manage and review safety data in accordance with GCP and regulatory requirements.
- Monitor and ensure data integrity across PV systems, submissions, and dashboards.
- Collaborate with Medical Affairs, Regulatory, and Clinical Operations to support safety reporting and regulatory submissions.
- Assist in creating and maintaining KPI dashboards and safety metrics.
What We're Looking For
- Bachelor's degree in Life Sciences or related field; pharmacovigilance experience preferred.
- Knowledge of regulatory requirements (FDA, GCP) and pharmacovigilance processes.
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