Director, Pharmacovigilance
Cabaletta Bio
August 09, 2026
Remote friendly (Philadelphia, PA)
United States
Operations
Position Description
- Director, Pharmacovigilance (global safety and pharmacovigilance) for clinical-stage CAR-T programs in autoimmune diseases. Reporting to the VP, Clinical Development. Based in Philadelphia, PA headquarters (hybrid) or remote.
Responsibilities
- Lead pharmacovigilance strategy; serve as safety lead on study teams for safety interpretation and risk management.
- Develop/maintain safety documents (e.g., DSURs, IBs, protocols, IND/BLA safety sections).
- Oversee SAE case processing and timely global reporting; lead signal detection, evaluation, and benefit-risk assessment.
- Escalate and communicate safety signals to stakeholders/governance committees.
- Ensure compliance with FDA/EMA/ICH PV regulations; support health authority interactions; contribute to audits/inspections.
- Partner cross-functionally (Clinical Development, Clinical Ops, Regulatory, Medical Affairs); provide safety input into trial design/data review; manage PV vendors (e.g., CROs, safety databases).
- Establish/refine PV processes 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).
- Prior cell/gene therapy or immunology experience strongly preferred.
- Ability to work cross-functionally and operate strategically and hands-on.
Benefits
- Competitive benefits, PTO, and stock option plans.
Application
- Apply via: https://www.cabalettabio.com/join-our-crew
- Director, Pharmacovigilance (global safety and pharmacovigilance) for clinical-stage CAR-T programs in autoimmune diseases. Reporting to the VP, Clinical Development. Based in Philadelphia, PA headquarters (hybrid) or remote.
Responsibilities
- Lead pharmacovigilance strategy; serve as safety lead on study teams for safety interpretation and risk management.
- Develop/maintain safety documents (e.g., DSURs, IBs, protocols, IND/BLA safety sections).
- Oversee SAE case processing and timely global reporting; lead signal detection, evaluation, and benefit-risk assessment.
- Escalate and communicate safety signals to stakeholders/governance committees.
- Ensure compliance with FDA/EMA/ICH PV regulations; support health authority interactions; contribute to audits/inspections.
- Partner cross-functionally (Clinical Development, Clinical Ops, Regulatory, Medical Affairs); provide safety input into trial design/data review; manage PV vendors (e.g., CROs, safety databases).
- Establish/refine PV processes 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).
- Prior cell/gene therapy or immunology experience strongly preferred.
- Ability to work cross-functionally and operate strategically and hands-on.
Benefits
- Competitive benefits, PTO, and stock option plans.
Application
- Apply via: https://www.cabalettabio.com/join-our-crew