Senior Drug Safety Specialist: Argus & SAE Expert

Exelixis Inc; Alameda (CA); Presencial; USD 131.000 - 185.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k plan

Medical/dental/vision insurance

Life and disability insurance

Discretionary bonus program

Stock purchase plan

Descripción de la vacante

Exelixis Inc. seeks a Drug Safety professional to manage SAE processing in the Argus database, ensure high-quality safety documentation, and oversee outsourced vendors.

You will code SAEs with MedDRA and support safety study operations while collaborating with Clinical Development, Regulatory Affairs, and Data Management. The role requires a clinical degree and 5–7 years in biotech/pharma, with strong regulatory knowledge and excellent writing skills.

Formación

• BS/BA or higher in a clinical field with 5+ years of related experience; or MS/MA with 5 years; or PhD with 0+ years.
• Experience in biotech/pharma and oncology preferred; Argus experience is a plus.
• Knowledge of regulatory framework governing patient safety; strong written and verbal communication.

Responsabilidades

• Process and assess SAEs from receipt to case closure in Argus.
• MedDRA coding of SAEs and AEs in source documents.
• Define high standard of case quality review with Drug Safety Physician.
• Schedule expedited safety reporting in ARGUS as needed.
• Train safety staff on Argus and case processing.
• Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management to ensure data handling.
• Lead Safety Study activities including reviews of IBs and study protocols.
• Develop and harmonize safety templates and forms across teams.

Conocimientos

SAE processing

MedDRA coding

Argus database

Pharmacovigilance

Educación

BS/BA in nursing or pharmacy

MS/MA in nursing or pharmacy

PhD in nursing or pharmacy

Herramientas

Argus Safety

Descripción del empleo

Exelixis Inc. seeks a Drug Safety professional to manage SAE processing in the Argus database, ensure high-quality safety documentation, and oversee outsourced vendors.

You will code SAEs with MedDRA and support safety study operations while collaborating with Clinical Development, Regulatory Affairs, and Data Management. The role requires a clinical degree and 5–7 years in biotech/pharma, with strong regulatory knowledge and excellent writing skills.