Senior PV Director, Late-Phase Biologics (Remote)

SAB; Sioux Falls (SD); Remote; USD 210,000 - 320,000; Full time

Job summary

SAB BIO is seeking an Executive Director of Pharmacovigilance to lead late‑phase global safety activities for its biologics portfolio. You will own end‑to‑end pharmacovigilance with oversight of ISS/ISE, CSR safety sections, PSURs and DSURs, and manage safety data operations worldwide.

The role requires an MD with 12+ years in pharmacovigilance, strong writing ability, and experience with global regulatory submissions.

Qualifications

• MD degree from an accredited institution is required.
• 12+ years of PV experience with senior-level accountability for late-phase programs.
• Experience authoring ISS/ISE and CSR safety sections for global filings.
• Experience with BLA/MAA submissions and regulatory interactions.
• Familiarity with ICH guidelines and global PV regulations.
• Leadership and cross-functional collaboration in small biotech or start-up environments.

Responsibilities

• Lead PV activities for Phase 3 and registrational biologics, ensuring regulatory compliance.
• Oversee global signal detection, evaluation, and safety reporting workflows.
• Serve as PV SME to cross-functional clinical, regulatory, and medical affairs teams.
• Maintain and oversee safety database and vendor relationships.

Skills

Leadership

Medical writing

Regulatory submissions

Cross-functional collaboration

Pharmacovigilance

Education

MD degree

Tools

Argus

ARISg

Job description

SAB BIO is seeking an Executive Director of Pharmacovigilance to lead late‑phase global safety activities for its biologics portfolio. You will own end‑to‑end pharmacovigilance with oversight of ISS/ISE, CSR safety sections, PSURs and DSURs, and manage safety data operations worldwide.

The role requires an MD with 12+ years in pharmacovigilance, strong writing ability, and experience with global regulatory submissions.