Jobs · Management · New Jersey

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.

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