Director, Pharmacovigilance

Position: Director, Pharmacovigilance (global safety & pharmacovigilance)
Location: Philadelphia, PA headquarters (hybrid) or remote; reports to VP, Clinical Development.

Responsibilities:
- Lead pharmacovigilance (PV) strategy across clinical programs; serve as safety lead for study teams.
- Develop/maintain safety documents (DSURs, IBs, protocols, safety sections of regulatory submissions such as INDs/BLAs).
- Oversee case processing (SAE review, medical assessment, timely global reporting).
- Lead signal detection, evaluation, and risk/benefit-risk assessment; escalate safety signals to stakeholders/governance committees.
- Ensure compliance with global PV regulations (FDA, EMA, ICH); support health authority interactions; aid audits/inspections.
- Partner cross-functionally (Clinical Development, Clinical Ops, Regulatory, Medical Affairs); provide safety input to trial design/data review.
- Manage PV vendors and build scalable PV capabilities.

Qualifications:
- Advanced degree (MD, PharmD, PhD, or equivalent) preferred.
- 8–10+ years PV/safety experience in biotech/pharma (including clinical-stage programs).
- Strong knowledge of global PV regulations (FDA/EMA/ICH).
- Clinical trial safety monitoring, signal detection, and aggregate reporting experience (e.g., DSURs).
- Cell & gene therapy or immunology experience strongly preferred.
- Cross-functional influence in matrixed environments; strategic and hands-on in fast-paced settings.

Benefits: competitive benefits, PTO, and stock option plans.
Application: Apply via https://www.cabalettabio.com/join-our-crew