Global Safety Physician - Strategy & Signal Leader

APX Life Sciences; Boston (MA); On-site; USD 230,000 - 320,000; Full time

Job summary

APX Life Sciences seeks a global safety physician to lead end-to-end medical safety strategy across the product lifecycle. You will serve as a core safety expert, drive risk-benefit assessments, and ensure safety input across clinical development plans, regulatory submissions, and governance forums.

The role requires minimum 3–5 years in pharmacovigilance or 6+ years in senior safety roles, with deep knowledge of FDA/EMA regulations and experience in DSURs, PBRERs, and risk management plans.

Qualifications

• Minimum 3–5 years in pharmacovigilance or 6+ years in senior roles within biotech/pharmaceutical development
• Working knowledge of global PV regulations and safety reporting requirements (FDA, EMA, ICH)
• Hands-on experience with DSUR, PBRER/PSUR, and risk management plans (RMPs)
• Experience authoring safety sections of regulatory submissions (IND/CTA, NDA/BLA/MAA)

Responsibilities

• Lead end-to-end safety strategy for assigned products across the lifecycle
• Direct safety data reviews and risk mitigation actions
• Participate in safety governance and executive safety committee presentations
• Review individual case safety reports (ICSRs) and expedited reporting determinations
• Author or contribute to key safety sections of regulatory submissions
• Engage with regulatory authorities and external safety committees
• Collaborate with Clinical Development, Regulatory, Biostatistics/Data Science and Quality teams

Skills

Pharmacovigilance

Safety strategy

Medical review

Signal detection

Regulatory submissions

Job description

APX Life Sciences seeks a global safety physician to lead end-to-end medical safety strategy across the product lifecycle. You will serve as a core safety expert, drive risk-benefit assessments, and ensure safety input across clinical development plans, regulatory submissions, and governance forums.

The role requires minimum 3–5 years in pharmacovigilance or 6+ years in senior safety roles, with deep knowledge of FDA/EMA regulations and experience in DSURs, PBRERs, and risk management plans.