Drug Safety Physician

• Part-Time Consultant
  
  

Position Summary

Our biotech client is seeking a hands-on physician consultant to provide medical safety and pharmacovigilance support for a Phase 1/2 oncology program. This role will focus entirely on clinical safety oversight. Medical monitoring, subject eligibility, and routine PV operations are handled separately.

The consultant must be available to complete SAE medical reviews within 24 hours.

Responsibilities

• Perform medical review and causality assessments for all SAEs.
• Determine SUSAR status and expectedness against the Investigator’s Brochure reference safety information.
• Provide safety input for DLT assessments and dose-escalation/Safety Review Committee meetings.
• Conduct aggregate safety reviews and ongoing signal assessments.
• Lead the medical sections of DSURs and Investigator’s Brochure safety updates.
• Provide medical oversight of the external PV vendor.
• Partner closely with Clinical Development, Regulatory Affairs, and other internal stakeholders.
  
  

The external PV vendor will manage case intake and processing, the safety database, MedDRA coding, expedited FDA and EudraVigilance submissions, and compilation of periodic reports.

Required Experience

• Physician with a medical degree and license that can be independently verified exactly as stated.
• Sponsor-side medical safety experience supporting early-phase oncology programs.
• Hands-on experience with SAE causality, SUSAR assessments, IND safety reporting, and EU Clinical Trials Regulation requirements.
• Experience contributing to DSURs and IB/RSI updates.
• Familiarity with immune-related toxicities.
  
  

Strongly Preferred

• Experience with CRS and ICANS.
• Experience supporting T-cell engagers, bispecific antibodies, cell therapy, or immuno-oncology programs.
• Prior involvement in DLT assessments and dose-escalation/Safety Review Committee meetings.
• Small-biotech experience and comfort working as a collaborative, hands-on individual contributor.