Executive Director, Medical Safety & PV – Immunology

Verto People; Somerville (MA); On-site; USD 350,000 - 520,000; Full time

Job summary

Verto People Ltd is seeking an Executive Director or VP of Medical Safety to lead global pharmacovigilance for immunology portfolios. You will drive safety strategy across preclinical to late-stage development, applying clinical and regulatory expertise in a fast-growing biotech setting.

You will shape safety governance, oversee external partners, and collaborate with Clinical, Regulatory and Translational Medicine teams, reporting to executive leadership.

Qualifications

• MD, MD-PhD or equivalent medical qualification – essential.
• 5–7+ years in medical safety, pharmacovigilance or clinical development.
• Proven leadership of clinical safety across early development.
• Strong understanding of immunology/inflammation.
• Experience with biologics, mAbs or oral therapeutics desirable.
• Expertise in AE assessment, signal detection and safety reporting.
• Knowledge of global PV regulations and FDA/EMA expectations.
• Experience overseeing CROs and external safety vendors.
• Ability to lead cross‑functional safety governance.
• Experience supporting IND/CTA submissions.

Responsibilities

• Define and lead global medical safety and pharmacovigilance strategies.
• Oversee safety activities from candidate selection through FIH and later stages.
• Lead benefit-risk assessments and risk mitigation across portfolios.
• Review SAEs, safety signals and immunogenicity risks.
• Oversee safety input into DSURs, PSURs/PBRERs and RMPs.
• Collaborate with Clinical Development, Regulatory Affairs and Operations.
• Review protocols, I.B.s and safety monitoring plans.
• Lead external pharmacovigilance vendors and ensure regulatory compliance.
• Represent safety in regulatory authority interactions.
• Establish safety governance frameworks and SOPs.
• Present safety assessments and development recommendations to leadership.

Skills

Medical safety leadership

Pharmacovigilance

IND/CTA submissions

Regulatory knowledge

Education

MD or MD-PhD or equivalent

Job description

Verto People Ltd is seeking an Executive Director or VP of Medical Safety to lead global pharmacovigilance for immunology portfolios. You will drive safety strategy across preclinical to late-stage development, applying clinical and regulatory expertise in a fast-growing biotech setting.

You will shape safety governance, oversee external partners, and collaborate with Clinical, Regulatory and Translational Medicine teams, reporting to executive leadership.