Senior Drug Safety Associate
Company: Meet Life Sciences
Location: San Diego
Posted on: March 17, 2026
|
|
|
Job Description:
Job Description 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.
Keywords: Meet Life Sciences, Anaheim , Senior Drug Safety Associate, Science, Research & Development , San Diego, California
