Oncology Pharmacovigilance Manager

Job Summary

Working remotely in a full-time capacity, the Oncology Pharmacovigilance Manager will develop and execute product safety strategies, manage signal detection and evaluation, and lead safety reporting and assessments throughout the product lifecycle.

Key responsibilities

• Lead signal detection, validation, and management activities while conducting scientific evaluations of adverse events
• Prepare and submit aggregate safety reports, ensuring quality and scientific integrity in safety assessments
• Provide strategic safety input into clinical protocols and collaborate with cross-functional teams to support ongoing safety surveillance

Required qualifications

• Doctorate degree or a Master's degree with 2 years of Industry Pharmacovigilance experience
• 5+ years of pharmacovigilance or drug safety experience within biotechnology, pharmaceutical, or CRO environments
• Experience authoring and reviewing aggregate safety reports, including PBRERs and DSURs
• Knowledge of FDA, EMA, ICH, and global pharmacovigilance regulations and guidance
• Demonstrated ability to influence and lead within a highly matrixed, cross-functional environment