A clinical-stage biotech is seeking a Safety Physician to support ongoing safety activities across late-stage clinical development programs. This role will focus on medical review of safety data, signal detection, and contribution to risk management strategies, ensuring high-quality safety oversight and regulatory compliance across Phase 3 studies.
This is a contract opportunity supporting innovative programs in autoimmune and neurology indications.
What You'll Do
- Provide medical review of ICSRs, including assessment of seriousness, expectedness, and causality
- Monitor safety data across multiple sources to ensure data quality and consistency
- Contribute to safety sections of clinical documents (protocols, IBs, ICFs, DSURs, safety reports)
- Support signal detection activities and participate in signal review discussions
- Review case listings and support resolution of coding or reconciliation discrepancies
Qualifications
- MD or international equivalent required with 3+ years of pharmacovigilance experience within global clinical trials
- Experience with ICSR medical review and safety data evaluation
- Working knowledge of MedDRA coding and safety databases
- Strong understanding of global PV regulations (FDA, EMA, ICH)
- Experience in autoimmune, neurology, or related therapeutic areas preferred
If you’re a Safety Physician looking to contribute to innovative clinical programs in a flexible contract setting, please apply or reach out to learn more: cait.dawson@rbwconsulting.com
