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Drug Safety Officer
وصف الوظيفة
Innovative oncology biotech is looking for a Senior Pharmacovigilance Consultant to provide strategic guidance on safety processes. You will lead pharmacovigilance activities including case review, signal detection, and risk management while ensuring compliance with FDA and EMA regulations. This is a senior role requiring 10+ years of experience in drug safety.
المسؤوليات
- Lead pharmacovigilance activities and case reviews
- Ensure compliance with global safety regulations (FDA/EMA)
- Provide PV expertise to cross-functional teams
- Drive safety strategy and risk minimization planning
- Mentor junior PV staff
- Support oversight of external vendors
المؤهلات
- 10+ years of experience in pharmacovigilance or drug safety
- Strong knowledge of FDA/US PV regulations
- Experience in oncology preferred
- Advanced knowledge of safety databases and signal detection