Drug Safety Specialist II - West Coast
Precision Medicine Group · San Francisco, CA · 1 wk ago
RemoteRemoteManagement$76k–$113k/yrFull-time
Responsibilities
- Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.
- Participate in the assessment and set-up of a safety database to capture SAE data.
- Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures.
- QC of documents and safety reports.
- Preparation and/or review of project-specific safety reporting plans and medical coding plans.
- Preparation and/or review of safety training materials.
- Provide safety training and oversight for consultants, contractors and/or staff.
- Review and/or draft standard operating procedures and work instructions.
- Aid clients and/or other departmental staff with safety-related reviews and other services.
Qualifications
- BA/BS degree
- Minimum 2 years safety experience
- Health care professional
- Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation
- Working knowledge of MedDRA and WHODrug
- Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.
- Nursing or pharmacy degree preferred
- Clinical trial safety experience
- Hands on experience with Argus
- Industry experience in CRO or pharmaceutical company preferred
Pay
Reasonable estimate of the current range: $75,600 - $113,400 USD
Schedule
Not specified
Benefits
Not specified
Skills
Not specified
Benefits
Not specified
Contact Information
Contact Precision Medicine Group at myHR@precisionmedicinegrp.com for more information.