Remote Position
Oncology Pharmacovigilance Manager
🌍 Remote · United States
💼 Full-time
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