Job Details

Senior Drug Safety Associate

Location: Bay Area, California (On-site, 5 days per week)

Company: Excelexis

About the Company

Excelexis is an innovative biotechnology company focused on advancing novel therapeutics to address serious and unmet medical needs. The team combines strong scientific expertise with a collaborative, fast-paced culture dedicated to bringing impactful treatments to patients. As the company continues to expand its clinical pipeline, they are looking to add a Senior Drug Safety Associate to support and strengthen their pharmacovigilance function.

This is an on-site position in the Bay Area (5 days per week)Relocation support is available, and the role comes with a very competitive compensation and benefits package

Position Overview

The Senior Drug Safety Associate will support global pharmacovigilance activities, ensuring the accurate collection, evaluation, and reporting of safety data from clinical trials and post-marketing sources. This individual will play a key role in maintaining compliance with global regulatory requirements while collaborating closely with Clinical, Regulatory Affairs, and external vendors.

Key Responsibilities

• Process and manage Individual Case Safety Reports (ICSRs) from clinical trials, literature, and spontaneous sources.
• Perform case intake, triage, data entry, coding (MedDRA/WHO-Drug), and quality review within the safety database.
• Ensure timely submission of safety reports to regulatory authorities in accordance with global reporting timelines (e.g., FDA, EMA).
• Assist with preparation and review of aggregate safety reports including DSURs, PSURs/PBRERs, and line listings.
• Support signal detection and safety data review activities as required.
• Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Medical Affairs to ensure complete and accurate safety information.
• Work with external pharmacovigilance vendors and CROs, ensuring quality and compliance with internal processes.
• Contribute to the development and maintenance of SOPs, work instructions, and pharmacovigilance processes
• Participate in internal audits and regulatory inspections as needed.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field
• 3–6+ years of pharmacovigilance / drug safety experience, preferably within biotech or pharmaceutical companies.
• Strong knowledge of global pharmacovigilance regulations and reporting requirements (FDA, ICH, EMA).
• Experience with safety databases (e.g., Argus, ArisG, or similar systems).
• Familiarity with MedDRA coding and safety case processing
• Excellent attention to detail and ability to manage multiple priorities in a fast-paced environment.
• Strong communication and collaboration skills.

Why Join

• Opportunity to join a growing biotech with an exciting clinical pipeline
• Highly competitive compensation package including salary, bonus, and equity.
• Relocation assistance available for candidates outside the Bay Area.
• Collaborative and mission-driven team environment.