Precision for Medicine
Drug Safety Specialist II - West Coast
Remote, United States · Mid
Sponsorship not specified$76k-$113kDetected 6 days ago
ICD-10FDA RegulatoryPharmacovigilance
About the role
- Essential functions of the job include but are not limited to:
Requirements
- Minimum Required:
- Minimum 2 years safety experience
- 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.
- Hands on experience with Argus
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
- BA/BS degree
- Other Required:
- Health care professional
- Preferred:
- Clinical trial safety experience
- #LI-KH1 #LI-Remote
Nice to have
- Nursing or pharmacy degree preferred
- Industry experience in CRO or pharmaceutical company preferred
Skills
- Participate in the assessment and set-up of a safety database to capture SAE data.
- 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.
- Assist clients and/or other departmental staff with safety-related reviews and other services.
- Other duties as assigned.
Compensation
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
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This listing is sourced directly from Precision for Medicine's careers page and normalized into a canonical job model.