Senior Global Safety Scientist & Strategy Lead

Alexion Pharmaceuticals, Inc.; Boston (MA); Hybrid; USD 133,000 - 199,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Health benefits

Job summary

Alexion Pharmaceuticals, Inc. seeks a Senior Manager, Safety Scientist within Global Patient Safety to evaluate and manage safety risks across product lifecycles in collaboration with GPS Medical Directors.

The role requires strict adherence to GxP, strong regulatory knowledge, and leadership of safety surveillance activities, with office-based work in Boston. Competitive base pay plus incentives and comprehensive benefits are provided.

Qualifications

• 3+ years of drug safety/pharmacovigilance experience
• Knowledge of global pharmacovigilance regulations
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Strong scientific writing skills
• Ability to work independently
• Good judgement
• Ability to interact with diverse teams globally
• Office-based role requiring computer use and collaboration

Responsibilities

• Contribute to safety data reviews and analyses for designated products
• Author or review safety sections of clinical documents
• Prepare aggregate safety reports (PSUR, PBRER, PADER) for regulators
• Oversee safety for assigned assets and safety governance
• Lead program and study-level safety surveillance and data analysis
• Author health authority queries and manage risk documentation

Skills

PV regulations

Analytical skills

Communication skills

Scientific writing

Independent work

Cross-functional teamwork

Education

Bachelor’s degree in biologic/medical/clinical/nursing field

Tools

MedDRA coding

Safety databases

Power BI

Spotfire

Job description

Alexion Pharmaceuticals, Inc. seeks a Senior Manager, Safety Scientist within Global Patient Safety to evaluate and manage safety risks across product lifecycles in collaboration with GPS Medical Directors.

The role requires strict adherence to GxP, strong regulatory knowledge, and leadership of safety surveillance activities, with office-based work in Boston. Competitive base pay plus incentives and comprehensive benefits are provided.