Senior Safety Scientist & PV Strategy Leader

Alexion Pharmaceuticals, Inc.; Boston, Northern (MA, KY); Hybrid; USD 126,000 - 190,000; Full time

Benefits offered by this job

Short-term incentives

Equity-based awards

Commissions

Retirement programs

Paid time off

Health/dental/vision coverage

Job summary

Alexion Pharmaceuticals, Inc. in Boston, MA seeks an Associate Director, Safety Scientist to provide strategic leadership within Global Patient Safety and manage safety risks across assigned products.

Based in Boston, you will collaborate with GPS Medical Directors and cross‑functional teams throughout product lifecycles. You will lead safety data reviews, author safety sections of protocols and reports, coordinate aggregate safety submissions, and support regulatory activities with high‑quality

Qualifications

• Bachelor’s degree in a biologic/medical/clinical/nursing field.
• At least 5+ years in pharmaceutical industry in drug safety/pharmacovigilance.
• Subject matter expertise in global pharmacovigilance regulations.
• Experience with clinical development including risk/benefit analysis and safety assessment.
• Strong analytical and problem‑solving skills.
• Excellent communication and interpersonal skills.
• Strong scientific writing skills.
• Ability to work independently and with cross-functional teams.
• Understanding of regulatory safety activities and PV governance.

Responsibilities

• Lead safety data reviews and analyses for designated products.
• Author or review safety sections of clinical documents and regulatory submissions.
• Coordinate and prepare high-quality aggregate safety reports (PSUR, PBRER, PADER).
• Oversee safety for assigned assets including Safety Strategy and Governance.
• Lead safety surveillance and communication of findings in cross-functional meetings.
• Author health authority queries and contribute to REMS documents.
• Maintain up-to-date knowledge of evolving global regulations.
• Represent global patient safety at regulatory inspections.
• Mentor and develop junior safety scientists and fellows.

Skills

Analytical skills

Communication skills

Scientific writing

Problem solving

Independent work

Interpersonal skills

Education

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

Advanced degree in biologic/medical/clinical/nursing field (PharmD/NP/PhD)

Tools

MedDRA

Power BI

Spotfire

Microsoft Word/PowerPoint/Excel

Job description

Alexion Pharmaceuticals, Inc. in Boston, MA seeks an Associate Director, Safety Scientist to provide strategic leadership within Global Patient Safety and manage safety risks across assigned products.

Based in Boston, you will collaborate with GPS Medical Directors and cross‑functional teams throughout product lifecycles. You will lead safety data reviews, author safety sections of protocols and reports, coordinate aggregate safety submissions, and support regulatory activities with high‑quality