Safety Specialist/Safety Lead

1 hour, 49 minutes ago
Senior
Operations
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised

Description

  • Develop safety management plans and project-specific safety reporting and medical coding plans.
  • Manage serious adverse event and suspected unexpected serious adverse reaction cases from intake through regulatory reporting.
  • Interface with sponsors, vendors, internal teams, clients, and study sites on safety processes and services.
  • Support the design and implementation of safety collection tools, processes, reporting systems, and safety databases.
  • Perform case intake, triage, data entry, medical coding, expectedness assessments, narrative writing, and similar-event analyses for individual case safety reports.
  • Conduct quality control of safety documents and reports.
  • Prepare and review safety training materials and provide training and oversight to consultants, contractors, and staff.
  • Draft and review standard operating procedures and work instructions.
  • Assist clients and internal departments with safety-related reviews and provide timely safety expertise.

Requirements

  • Bachelor’s degree or equivalent BA/BS qualification.
  • At least 5 years of safety experience.
  • Healthcare professional background.
  • Hands-on experience with global safety databases, SAE case processing, narrative writing, and safety report 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 preferred.
  • Hands-on experience with Argus preferred.
  • CRO or pharmaceutical industry experience preferred.

Interested in this position?

Apply directly on the company website

Apply Now

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