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Drug Safety Lead

1 hour, 52 minutes ago
South Korea
Full-time
Lead
Program Manager
Project and Program Management
Apply Now
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
View All Jobs 111

Description

  • Lead project-specific safety and pharmacovigilance meetings, including kick-off meetings, internal study meetings, and client governance meetings.
  • Oversee serious adverse event (SAE) and SUSAR case management from intake through regulatory reporting.
  • Review safety budgets and approve safety budget activities as needed.
  • Develop safety management plans, safety reporting plans, medical coding plans, and safety training materials.
  • Support the design and implementation of safety collection tools, processes, reporting systems, and safety databases.
  • Perform quality control of documents and safety reports when needed.
  • Develop and maintain standard operating procedures and work instructions.
  • Serve as a subject matter expert for the department and provide timely safety expertise to internal teams, clients, and study sites.
  • Train and mentor Safety Specialists and assist departmental management with resource oversight.
  • Participate in audits, audit preparation, CAPA management, investigator meetings, and bid defenses for current and prospective clients.
  • Serve as project manager for standalone safety projects and lead departmental initiatives and cross-functional development activities.
  • Support SAE/AESI query generation, tracking, escalation, and responses to regulatory agency questions related to safety and pharmacovigilance.

Requirements

  • BA/BS degree required.
  • 10+ years of clinical safety experience required.
  • 5+ years of pharmacovigilance experience required.
  • Current or prior experience as a health care professional.
  • Hands-on experience with global safety databases, SAE case processing, and safety report generation.
  • Working knowledge of MedDRA and WHODrug.
  • Working knowledge of FDA safety regulations, ICH guidelines, and global regulations.
  • Demonstrated knowledge of regulatory guidance for safety reporting and processing in clinical trial environments.
  • Demonstrated experience supporting internal audits, inspection readiness, and regulatory inspection support, including BLA or NDA approval inspections.
  • Excellent written and verbal communication and analytical skills.
  • Ability to communicate complex clinical issues clearly and scientifically.
  • Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
  • Preferred: early-phase oncology clinical trial experience.

Benefits

  • Opportunity to work on ground-breaking cancer therapies in oncology and rare disease.
  • Role in a growing organization with employee ideas valued and nurtured.
  • Ability to make a meaningful impact on the company through input and initiative.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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