Drug Safety Specialist II – SAE & MedDRA Expert

Exelixis Inc; Alameda (CA); On-site; USD 105,000 - 148,000; Full time

Benefits offered by this job

401k plan

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock purchase plan

Long-term incentives

Vacation days

Paid holidays

Sick days

Job summary

Exelixis Inc. seeks a Drug Safety professional to provide expertise in safety case processing, ensuring documentation quality for SAEs and data submitted in Argus.

You will work with cross-functional teams and external vendors to maintain regulatory compliance and high data integrity across safety reporting. The role requires a BS/BA in a clinical field with 3–5+ years of related experience, preferably with Biotech/Pharma and Argus experience.

Qualifications

• BS/BA in Nursing, Pharmacy or related discipline with 5+ years of relevant experience; or an MS/MA with 3+ years; or a PhD with applicable experience.
• Regulatory knowledge in biotech/pharma and clinical safety is required.
• Experience with Argus safety database and SAE processing is preferred.

Responsibilities

• Process and assess SAEs from receipt to case closure in Argus with narratives and ASE writing.
• MedDRA coding of SAEs and AEs and development of coding conventions.
• Perform high-quality safety data documentation with medical oversight.
• Coordinate submission of expedited safety reports as needed.
• Collaborate across Clinical Development, Data Management, Regulatory Affairs, and others.

Skills

SAE processing

Argus safety database

MedDRA coding

Pharmacovigilance knowledge

Vendor oversight

Education

BS/BA in Nursing or Pharmacy or related

MS/MA in Nursing or related

PhD in Nursing/Pharmacy or related

Tools

Argus Safety

Job description

Exelixis Inc. seeks a Drug Safety professional to provide expertise in safety case processing, ensuring documentation quality for SAEs and data submitted in Argus.

You will work with cross-functional teams and external vendors to maintain regulatory compliance and high data integrity across safety reporting. The role requires a BS/BA in a clinical field with 3–5+ years of related experience, preferably with Biotech/Pharma and Argus experience.