Temporary Drug Safety Associate II

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

We are seeking a Drug Safety Associate II to support pharmacovigilance operations through case processing, safety data review, and regulatory reporting activities. This role is responsible for managing adverse event cases, ensuring accurate safety documentation, and supporting compliance with global pharmacovigilance requirements.

Position Overview

We are seeking a Drug Safety Associate II to support pharmacovigilance operations through case processing, safety data review, and regulatory reporting activities. This role is responsible for managing adverse event cases, ensuring accurate safety documentation, and supporting compliance with global pharmacovigilance requirements.

Key Responsibilities

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

Required Qualifications

• Bachelor's degree in a scientific, healthcare, nursing, pharmacy, or related discipline; advanced degree or equivalent experience may be considered.
• 5+ years of pharmacovigilance experience within pharmaceutical, biotechnology, CRO, or related environments.
• Strong end-to-end case processing experience, including intake, assessment, MedDRA coding, narrative writing, follow-up activities, expedited reporting, and quality review.
• Minimum 3 years of hands-on experience with Argus Safety Database.
• Experience processing both clinical trial and post-marketing adverse event cases.
• Strong understanding of global pharmacovigilance regulations, safety reporting requirements, and case management practices.
• Strong analytical, organizational, and communication skills.
• Ability to manage multiple priorities while maintaining accuracy and compliance.

Preferred Qualifications

• Experience in oncology or other specialty therapeutic areas.
• Experience working within a CRO or outsourced pharmacovigilance environment.
• Experience supporting audits, inspections, or pharmacovigilance compliance initiatives.
• Clinical background in Nursing, Pharmacy, or a related healthcare discipline.

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [e-mail].