Safety Lead

1 hour, 58 minutes ago
Full-time
Lead
Project and Program Management
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

  • Lead project safety meetings, client governance activities, budget reviews, and safety management plan development.
  • Oversee serious adverse event and suspected unexpected serious adverse reaction case management from intake through regulatory reporting.
  • Support the design and implementation of safety collection tools, processes, databases, and reporting systems.
  • Prepare and review safety reporting plans, medical coding plans, training materials, documents, and safety reports.
  • Develop and manage standard operating procedures and work instructions.
  • Provide safety subject-matter expertise, training, mentorship, and support to internal teams, clients, vendors, and study sites.
  • Participate in audits, inspection readiness, investigator meetings, CAPA activities, and regulatory agency responses.
  • Manage SAE/AESI queries and escalation of query-resolution activities.
  • Serve as project manager for standalone safety projects and lead departmental and cross-functional initiatives.
  • Support resource management, departmental oversight, bid defenses, and safety-related client services.

Requirements

  • BA/BS degree.
  • 10+ years of clinical safety experience.
  • 5+ years of pharmacovigilance experience.
  • Healthcare professional background.
  • Hands-on experience with global safety databases, SAE case processing, and safety report generation.
  • Working knowledge of MedDRA, WHODrug, FDA safety regulations, ICH guidelines, and global regulations.
  • Knowledge of regulatory requirements for clinical trial safety reporting, processing, audits, inspections, BLA, and NDA approval inspections.
  • Excellent written, oral, analytical, and scientific communication skills.
  • Ability to explain complex clinical issues clearly and work effectively in a fast-paced, flexible, and resourceful environment.
  • Nursing or pharmacy degree, CRO or pharmaceutical industry experience, and project management experience preferred.

Interested in this position?

Apply directly on the company website

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