Drug Safety Associate Director

Posted 9 days ago

virtual vocationsNew York (NY)

SENIORITY

Manager

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About the role

To support a growing safety team, the full-time Associate Director, Drug Safety will oversee outsourced pharmacovigilance activities, contribute to regulatory and safety deliverables, and collaborate with various departments while working remotely.
Key Responsibilities: Provide oversight of SAE processing activities and monitor vendor performance Contribute to aggregate safety reports and coordinate safety data deliverables for regulatory submissions Co-author and maintain controlled documents to ensure compliance and inspection readiness
Required Qualifications: Bachelor's degree in nursing or pharmacy; advanced degree such as PharmD, MSN, or MPH preferred At least 10 years of experience in pharmacovigilance or drug safety, with relevant experience in safety science/surveillance preferred Strong understanding of MedDRA and WHODrug dictionaries Proficiency in Safety Databases and knowledge of global pharmacovigilance regulations Oncology phase I to III experience preferred

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