VP Pharmacovigilance

Vice President, Pharmacovigilance | Rare Neuroscience Biotech | East Coast

I’m partnering exclusively with a privately held, East Coast-based biotechnology company to appoint a Vice President of Pharmacovigilance to lead global safety strategy across its growing neuroscience studies.

With programs progressing through late-stage global clinical development, including pivotal development in rare neurodevelopmental disease, this is an opportunity to join at an important point in the company’s evolution and take ownership of the pharmacovigilance function.

Reporting directly into a highly respected drug‑development leader with extensive experience across neuroscience and rare disease, the VP Pharmacovigilance will have broad responsibility for the company’s global safety strategy.

Rather than inheriting a large, established PV organization, this person will have the opportunity to shape how safety is built and operated as the portfolio matures, working closely with Clinical Development, Regulatory, Quality and external partners.

• Own and lead the global pharmacovigilance and drug safety strategy across clinical-stage programs.
• Provide senior safety leadership across ongoing and future global clinical trials, including late-stage/pivotal development.
• Lead benefit-risk assessment, signal detection, safety surveillance and ongoing evaluation of emerging clinical safety data.
• Provide strategic safety input into clinical development plans, protocols, regulatory submissions and interactions with global health authorities.
• Oversee aggregate safety reporting including DSURs and other required regulatory safety documentation.
• Ensure appropriate processes for adverse event collection, assessment, reporting and reconciliation.
• Lead and oversee external PV vendors and safety partners, ensuring quality, compliance and effective execution.
• Establish and evolve pharmacovigilance infrastructure, governance and processes appropriate for a growing biotechnology company.
• Partner closely with Clinical Development, Regulatory Affairs, Clinical Operations, Quality and senior leadership.
• Support future portfolio expansion, regulatory filings and ultimately the transition toward commercialization.

We are looking to speak with established VP-level Pharmacovigilance / Drug Safety leaders who have operated within clinical-stage biotechnology or pharmaceutical environments.

• Significant leadership experience across Pharmacovigilance and Drug Safety.
• Experience owning safety strategy for global clinical development programs.
• Strong knowledge of US and international pharmacovigilance regulations and requirements.
• Experience supporting late-stage clinical development and regulatory submissions.
• Ability to operate strategically while remaining close enough to the programs to provide hands‑on safety leadership.
• Experience managing outsourced PV models, CROs and specialist vendors.
• Strong cross-functional leadership and the ability to work effectively with Clinical Development, Regulatory and Quality.
• Neuroscience, rare disease, pediatric or genetic disease experience would be highly relevant.

This is an opportunity to become the senior safety leader within a well-capitalized neuroscience organization at a point where its clinical programs are becoming increasingly mature and global.

The position offers genuine ownership of global safety strategy, direct access to senior leadership and the opportunity to build a function rather than simply operate within an established structure.

For someone who wants the scientific focus and influence of a smaller biotech without the same funding constraints faced by many emerging companies, it represents a particularly interesting opportunity.

The search is being conducted confidentially.