Oncology Pharmacovigilance Manager

Posted today

virtual vocationsNew York (NY)

SENIORITY

Manager

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About the role

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 surveillanceRequired qualificationsDoctorate 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

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