Senior Drug Safety Specialist: SAE & Argus Lead

Exelixis, Inc.; Alameda (CA); Híbrido; USD 131.000 - 185.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401k plan

Medical/dental/vision coverage

Bonus program

Stock options

Paid time off

Descripción de la vacante

Exelixis, Inc. is seeking a Drug Safety Associate III in Alameda, CA to provide pharmacovigilance expertise and ensure high-quality safety documentation for SAEs. You will oversee case processing in Argus and coordinate with outsourced vendors and cross-functional teams.

The role requires a nursing/pharmacy/clinical background with 5–7+ years’ related experience, and the ability to train others and manage safety study activities across the drug safety lifecycle.

Formación

• Experience in Biotech/pharmaceutical industry and oncology preferred.
• Experience with Argus safety database preferred.
• Clinical trial and spontaneous adverse event processing experience.

Responsabilidades

• Process and assess SAEs from receipt to case closure in Argus.
• MedDRA coding of SAEs and AEs; develop coding conventions.
• Ensure high-quality safety data documentation and case quality review.
• Schedule submissions of expedited safety reports as needed.
• Train new safety staff on Argus and case processing.
• Collaborate with Clinical Development, Data Management, Regulatory Affairs, and Project Management.
• Lead safety studies: review IBs, protocols, and IND annual reports; develop/refresh safety management plans.

Conocimientos

Analytical thinking

Time management

Communication skills

Team collaboration

Educación

BS/BA in Nursing/Pharmacy/clinical discipline

MS/MA in Nursing/Pharmacy/clinical discipline

PhD in Nursing/Pharmacy/clinical discipline

Herramientas

Argus safety database

Descripción del empleo

Exelixis, Inc. is seeking a Drug Safety Associate III in Alameda, CA to provide pharmacovigilance expertise and ensure high-quality safety documentation for SAEs. You will oversee case processing in Argus and coordinate with outsourced vendors and cross-functional teams.

The role requires a nursing/pharmacy/clinical background with 5–7+ years’ related experience, and the ability to train others and manage safety study activities across the drug safety lifecycle.