New Drug Safety Specialist II - West Coast

Position Summary:

• Responsibilities include safety management plan development, serious adverse event case management, and providing safety expertise.
• Collaborate with sponsors, vendors, and internal teams to design safety collection tools and processes.

Essential Functions:

• Perform intake, triage, data entry, medical coding, and narrative composition for individual case safety reports.
• QC documents and safety reports; prepare project-specific safety plans and training materials.
• Provide safety training and oversight; review and draft standard operating procedures.

Qualifications:

• BA/BS degree and minimum 2 years safety experience required; health care professional preferred.
• Hands-on experience with global safety databases, SAE case processing, and safety report generation.
• Working knowledge of MedDRA, WHODrug, FDA and ICH safety regulations.

Benefits:

• Eligible for discretionary annual bonus, health insurance, retirement savings, life insurance, disability benefits.
• Paid time off for sick leave and vacation, and parental leave.