Senior Executive Director, Pharmacovigilance

Role Overview:

• Serve as Head of Pharmacovigilance with accountability for safety strategy and operations.
• Build a fit-for-purpose PV function designed to scale as assets advance through development.
• Operate as both strategist and practitioner in a lean organization.

Key Responsibilities:

• Ensure timely and compliant regulatory reporting (SUSARs, DSURs) to FDA, EMA, and other authorities.
• Provide oversight of outsourced PV vendors, including safety database management and case processing.
• Build and maintain a right-sized PV quality system and lead inspection-readiness activities.

Qualifications:

• Bachelor's degree with 10-15 years of industry experience and at least 10 years in pharmacovigilance.
• Deep knowledge of global PV regulations (21 CFR, ICH, EU GVP) and proven vendor oversight experience.
• Experience supporting health authority inspections and scaling a PV function from early to late-stage development.

Position Location:

• This is a remote role with periodic travel to team and company events.
• The anticipated salary range is $250K-$330K depending on level.
• Authorization to work in the United States is required.