Global Safety Physician (D/SD Level)

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 are seeking a global safety physician with experience in leading end-to-end safety strategy. The incumbent will serve as a core medical safety expert across the development organization and be responsible for pipeline level medical safety oversight. Highly cross-functional, highly visible opportunity at a fast paced, capitalized clinical stage biotech.

Key Responsibilities

Safety Strategy & Benefit-Risk Leadership

• Serve as the accountable medical safety expert for one or more assigned investigational products, owning the strategic safety plan across the product lifecycle
• Lead ongoing benefit-risk assessment and ensure it is clearly and consistently reflected in clinical, regulatory, and safety documents
• Provide medical safety input into clinical development plans, protocols, statistical analysis plans, and investigator brochures

Signal Management & Medical Review

• Lead signal detection, evaluation, and management activities
• Direct aggregate safety data reviews (e.g., blinded/unblinded data review, DSUR/PBRER, ad hoc safety reviews) and drive appropriate risk mitigation actions
• Participate in the safety governance activities: chair or co-chair internal Safety Management Team meetings and present at the Executive Safety Committee for assigned products
• Provide medical review and assessment of individual case safety reports (ICSRs), including expedited reporting determinations, in partnership with PV operations
• Develop and maintain risk management plans (RMPs) and associated risk minimization strategies
• Author or contribute to key safety sections of regulatory submissions (IND/CTA, briefing documents, NDA/BLA/MAA components, responses to Health Authority queries)
• Represent Patient Safety in interactions with FDA, EMA, and other regulatory authorities, as well as with external Data Monitoring Committees (DMCs)

Internal & External Collaboration

• Partner closely with Clinical Development, Regulatory, Biostatistics/Data Science, Clinical Pharmacology, Quality, and Legal on all matters affecting product safety
• Stay current on relevant literature, competitive safety landscape, and evolving global PV regulations affecting assigned therapeutic areas

Required Qualifications

• Minimum 3–5 years (Medical Director) or 6+ years (Senior Medical Director) of pharmacovigilance/drug safety experience in the biotech/pharmaceutical industry, or equivalent clinical development experience with strong safety/benefit-risk exposure
• Working knowledge of global PV regulations and safety reporting requirements, including FDA, EMA, and ICH E2 guidelines (E2A, E2B, E2C, E2E, E2F)
• Hands-on experience with signal detection methodology, aggregate safety reporting (DSUR, PBRER/PSUR), and development/maintenance of risk management plans (RMPs)
• Demonstrated experience authoring or substantively contributing to safety sections of regulatory submissions (IND/CTA, IB, NDA/BLA/MAA components)

Prior experience in Small Molecule Immunology/Inflammation is preferred.