Senior Global Safety Scientist & Leader

Alexion Pharma Spain S.L.; Boston (MA); Sur place; USD 133 000 - 199 000; Plein temps

Avantages offerts par ce poste

Paid time off

Health, dental, and vision coverage

Retirement plans

Incentive bonuses

Résumé du poste

Alexion Pharma Spain S.L. is seeking an Associate Director, Safety Scientist to provide strategic safety leadership within Global Patient Safety. You will lead safety data reviews, author safety sections for key documents, and manage global aggregate safety reports for regulatory agencies.

The role requires a Bachelor's in a biological/medical field and 5+ years in pharmacovigilance, with strong writing and communication skills to mentor juniors and interact with cross-functional teams globally.

Qualifications

• Bachelor’s degree in a biologic/medical/clinical/nursing field.
• Minimum 5+ years in pharmaceutical safety/pharmacovigilance.
• Experience preparing aggregate safety reports and signal surveillance.
• Experience with clinical development safety assessment and risk/benefit analysis.
• Strong written and verbal communication, and ability to work independently.

Responsabilités

• Lead safety data reviews and analyses for designated therapeutic areas.
• Author or review safety sections of protocols, ICFs, and CSR documents.
• Coordinate and prepare PSURs, PBRERs, PADERs for regulatory submissions.
• Oversee safety for assigned assets and implement Safety Strategy and Mgt Team.
• Lead safety surveillance at program and study levels and communicate results.
• Prepare health authority responses and manage regulatory interactions.
• Mentor junior safety scientists and contribute to training.
• Support regulatory filings and eCTD module inputs.

Connaissances

Pharmacovigilance

Safety data analysis

Regulatory communications

Scientific writing

Cross-disciplinary collaboration

Formation

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

Outils

MedDRA coding

Power BI

Spotfire

Description du poste

Alexion Pharma Spain S.L. is seeking an Associate Director, Safety Scientist to provide strategic safety leadership within Global Patient Safety. You will lead safety data reviews, author safety sections for key documents, and manage global aggregate safety reports for regulatory agencies.

The role requires a Bachelor's in a biological/medical field and 5+ years in pharmacovigilance, with strong writing and communication skills to mentor juniors and interact with cross-functional teams globally.