Precision for Medicine

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.

This listing is sourced directly from Precision for Medicine's careers page and normalized into a canonical job model.