Remote Global PV Lead, Biologics Safety & Regulatory

SAB; Tulsa (OK); Remote; USD 180,000 - 260,000; Full time

Job summary

SAB BIO in the United States is seeking an Executive Director, Pharmacovigilance to lead global safety operations for late-phase biologics and regulatory submissions. The role combines senior scientific leadership with hands-on PV execution in a resource-lean biotech setting.

The incumbent will oversee global signal detection, safety data processing, and regulatory documentation (ISS, ISE, DSURs, PSURs), mentor PV staff, manage CROs, and ensure compliance with ICH, FDA/EMA guidelines and

Qualifications

• MD degree is required.
• 12+ years in pharma/biotech PV with senior responsibilities.
• Authored ISS/ISE for at least one BLA/MAA preferred.
• Experience authoring CSR, DSURs, PSURs/PBRERs for biologics.
• Deep knowledge of ICH guidelines and global PV regs.
• Strong CRO/vendor PV management and safety database oversight.

Responsibilities

• Lead PV activities for Phase 3 and registrational biologics.
• Oversee global signal detection, evaluation, and reporting.
• Manage safety data receipt, processing, and CRO collaborations.
• Serve as PV subject-matter expert to cross-functional teams.
• Maintain global safety database and AE reporting infrastructure.
• Coordinate regulatory safety documents (ISS, ISE, PSURs, DSURs).

Skills

PV leadership

Regulatory submissions

Medical writing

Cross-functional collaboration

Education

MD degree

Tools

Argus

ARISg

Job description

SAB BIO in the United States is seeking an Executive Director, Pharmacovigilance to lead global safety operations for late-phase biologics and regulatory submissions. The role combines senior scientific leadership with hands-on PV execution in a resource-lean biotech setting.

The incumbent will oversee global signal detection, safety data processing, and regulatory documentation (ISS, ISE, DSURs, PSURs), mentor PV staff, manage CROs, and ensure compliance with ICH, FDA/EMA guidelines and