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
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
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