Director/Senior Director Safety Physician
Alpha Clinical · New Jersey, United States · 4 mo ago
ManagementFull-time
Position Summary
Oversee Patient Safety activities for assigned oncology compounds.
Prepare and review safety documents (DSURs, PSURs, RMPs).
Requirements
- MD degree
- Expertise in FDA, EU, and ICH pharmacovigilance guidelines
Qualifications
- Leadership of cross-functional Safety Monitoring Teams
- Representation of GPS on internal and external committees
- Proactive development of GPS strategies
- Participation in SOP development
- Engagement in continuous improvement efforts
Skills
- Applying FDA, EU, and ICH guidelines for pharmacovigilance in clinical trials and post-marketing
- Acting as an internal and external safety expert
- Using safety databases for case reviews
- Strong communication skills to present and defend safety findings and risk management strategies
Benefits
N/A
Pay
N/A
Schedule
N/A
Job Nature
Full-time
Job Location
N/A
Job Level
N/A
How to Apply
Interested candidates can send their resumes to info@acdlimited.com mentioning "Job Title" in the subject line.