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 readinessRequired QualificationsBachelor'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
