Job Details
Posted 26 October, 2026
Job Id: 631992
Drug Safety Physician
Job Description
*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.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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