Sr. Director Pharmacovigilance

About the Company

A well-funded, clinical-stage biotech focused on developing next-generation immune-based therapies for autoimmune diseases. The team is working on novel approaches designed to improve patient outcomes and expand access to treatment.

The Role

Senior Director, Pharmacovigilance (PV)

This is a high-impact, build-stage role where you'll lead and own the safety function across clinical programs. You'll work closely with clinical and executive leadership, balancing hands-on execution with strategic oversight.

What You'll Be Doing

• Lead global pharmacovigilance activities across clinical programs
• Oversee case processing (ICSRs) and aggregate reporting (DSURs)
• Provide safety input into clinical and regulatory documents
• Partner closely with clinical, medical, and regulatory teams
• Manage vendors/CROs and external partners
• Build and improve PV processes, SOPs, and systems
• Support regulatory interactions and inspections

What They're Looking For

• Strong background in drug safety / pharmacovigilance (biotech or pharma)
• Clinical-stage experience (Phase II-III preferred)
• Healthcare background (physician, PharmD, etc.)
• Solid understanding of global PV regulations and reporting
• Comfortable in a hands-on, fast-paced environment

Why It's Interesting

• High visibility role with leadership exposure
• Opportunity to build and shape the PV function
• Collaborative, low-ego team environment
• Well-funded with strong momentum