Senior Drug Safety Associate — Case Processing & Reporting

Advanced Clinical; Alameda (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health coverage

Life insurance

Disability insurance

401k plan

Job summary

Advanced Group in California is seeking a Drug Safety Associate II to support pharmacovigilance operations through case processing, safety data review, and regulatory reporting activities.

You will manage adverse event cases from intake to closure, perform MedDRA coding and narrative writing, and ensure timely, compliant safety documentation across global requirements. Experience with Argus Safety is preferred.

Qualifications

• Bachelor's degree in a scientific, healthcare, nursing, pharmacy, or related discipline.
• 5+ years of pharmacovigilance experience in pharma/biotech/CRO environments.
• Strong end-to-end case processing experience including intake, assessment, MedDRA coding, narrative writing, follow-up, expedited reporting, and QA.

Responsibilities

• Manage adverse event and serious adverse event cases from intake through closure.
• Perform case assessment, MedDRA coding, narrative writing, follow-up activities, and quality review.
• Ensure timely processing of safety cases within safety databases.
• Support expedited safety reporting and regulatory submissions.
• Conduct quality reviews for completeness, accuracy, and compliance of safety documentation.
• Collaborate with cross-functional teams for safety data collection, review, and reporting.
• Maintain safety documentation and support process improvements and compliance initiatives.
• Escalate safety concerns and case processing issues as appropriate.

Skills

Pharmacovigilance

Case processing

Safety reporting

Regulatory compliance

Education

Bachelor's degree in a scientific/healthcare field

Tools

Argus Safety Database

Job description

Advanced Group in California is seeking a Drug Safety Associate II to support pharmacovigilance operations through case processing, safety data review, and regulatory reporting activities.

You will manage adverse event cases from intake to closure, perform MedDRA coding and narrative writing, and ensure timely, compliant safety documentation across global requirements. Experience with Argus Safety is preferred.