Associate Director/Director, Patient Safety Operations
$186,666–$251,068 year
On-site · Carlsbad, California, United States or Boston, Massachusetts, United States
Job Summary
This position oversees Patient Safety Operations, focusing on clinical development and post-marketing pharmacovigilance. Responsibilities include managing case processing workflows, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams. The role requires strong leadership in vendor management, a deep understanding of global pharmacovigilance regulations, and experience with safety database management. Candidates should possess at least 12 years of drug safety experience and a degree in life sciences.
Required Qualifications
- Minimum 12 years of working experience within drug safety and pharmacovigilance
- Degree in life sciences or equivalent experience
- Excellent communication skills including proficiency in verbal and written English
- Proficiency in all commonly used Microsoft applications
- Strong understanding of global pharmacovigilance regulations
Desired Qualifications
- Experience with Argus
- Knowledge of Veeva, eTMF, and EDC
- Prior involvement in inspections or audits
Additional Requirements
- NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
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