Global Head of Medical Safety & Pharmacovigilance

AiLux S.r.l.; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

AiLux is seeking a Medical Safety Leader (U.S.-based) to own the integrated medical safety strategy for biologics and oral therapies targeting immune-mediated diseases. You will translate nonclinical and clinical data into clear safety narratives, oversee surveillance, risk management, and regulatory interactions, and shape governance across the portfolio.

Lead cross-functional teams in safety strategy from candidate selection through early human trials, daily pharmacovigilance operations, and

Qualifications

• MD or MD-PhD with clinical training in immunology or related fields.
• 5–7+ years in biotech/pharma medical safety, pharmacovigilance, or clinical development.
• Experience leading safety from preclinical through PoC and beyond.
• Global PV regulations knowledge (FDA, EMA, NMPA).

Responsibilities

• Develop integrated medical safety strategy across portfolio.
• Direct safety surveillance and signal management.
• Oversee medical review of aggregate reports (DSURs, PSURs, RMPs).
• Represent safety to executives, DSMBs, health authorities, and partners.

Skills

Medical safety

Pharmacovigilance

DSUR PSUR

Regulatory knowledge

Cross-functional leadership

Education

MD or MD-PhD

Job description

AiLux is seeking a Medical Safety Leader (U.S.-based) to own the integrated medical safety strategy for biologics and oral therapies targeting immune-mediated diseases. You will translate nonclinical and clinical data into clear safety narratives, oversee surveillance, risk management, and regulatory interactions, and shape governance across the portfolio.

Lead cross-functional teams in safety strategy from candidate selection through early human trials, daily pharmacovigilance operations, and