Senior Safety Scientist & Global PV Strategy Lead

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

Benefits offered by this job

401(k) plan

Health benefits

Annual bonus

Job summary

Alexion Pharmaceuticals, Inc. in Boston, MA is seeking a Senior Manager, Safety Scientist to lead safety governance for assigned assets. You will collaborate with GPS Medical Directors and cross-functional teams to evaluate risks and drive safety strategy throughout development and lifecycle.

The role requires 3+ years in pharmacovigilance with strong writing, data analysis, and regulatory reporting experience. Office-based with potential cross-functional opportunities across global teams.

Qualifications

• Bachelor’s degree in biologic/medical/clinical/nursing field; 3+ years in drug safety/pharmacovigilance.
• Knowledge of global pharmacovigilance regulations.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Strong scientific writing skills.
• Ability to work independently and exercise good judgement.

Responsibilities

• Contribute to safety data reviews and analyses for designated products.
• Author/review safety sections in clinical documents (protocols, ICFs, IGBs, SAPs, CSR, DMC documents).
• Coordinate safety reports (PSUR, PBRER, PADER) for regulatory submissions.
• Oversee safety for assets, implement Safety Strategy and SST/SSaMT.
• Lead safety surveillance and communicate results to cross-functional teams.

Skills

Global pharmacovigilance regulations

Analytical skills

Communication skills

Scientific writing

Independent working

Good judgement

Cross-cultural collaboration

Data visualization tools

Education

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

Advanced degree (PharmD/MD/NP/PhD)

Tools

Power BI

Clinical safety databases

Job description

Alexion Pharmaceuticals, Inc. in Boston, MA is seeking a Senior Manager, Safety Scientist to lead safety governance for assigned assets. You will collaborate with GPS Medical Directors and cross-functional teams to evaluate risks and drive safety strategy throughout development and lifecycle.

The role requires 3+ years in pharmacovigilance with strong writing, data analysis, and regulatory reporting experience. Office-based with potential cross-functional opportunities across global teams.