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Drug Safety Lead

1 day, 17 hours ago
South Korea
Full-time
Lead
Operations Manager
Operations
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 132

Description

  • Lead project-specific meetings, including kickoffs, internal study meetings, and client governance meetings.
  • Review and approve safety budgets and develop safety management plans as needed.
  • Oversee serious adverse event and SUSAR case management from intake through regulatory reporting.
  • Collaborate with sponsors, vendors, and internal teams to design and implement safety collection tools, processes, and reporting systems.
  • Participate in the setup of safety databases to capture SAE data.
  • Review and quality check safety documents, reports, training materials, and medical coding plans.
  • Develop and maintain standard operating procedures and work instructions.
  • Serve as a department subject matter expert and provide timely safety expertise to team members, clients, and site personnel.
  • Train and mentor Safety Specialists and support departmental resource and oversight needs.
  • Participate in audits, audit preparation, CAPA management, bid defenses, investigator meetings, and regulatory response review.
  • Lead safety standalone projects, departmental initiatives, and cross-functional development activities.
  • Support SAE/AESI query generation, tracking, escalation, and resolution efforts.

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 and WHODrug.
  • Working knowledge of FDA safety regulations, ICH guidelines, and global regulations.
  • Demonstrated knowledge of regulatory requirements for safety reporting and clinical trial processing.
  • Experience supporting internal audits, inspection readiness, and regulatory agency inspections, including BLA or NDA approval inspections.
  • Excellent written and oral communication skills and strong analytical judgment.
  • Ability to communicate complex clinical issues clearly and scientifically.
  • Experience in early-phase oncology clinical trials is preferred.

Benefits

  • Opportunity to work on groundbreaking cancer therapies in oncology and rare disease.
  • Employee ideas are valued and encouraged, with opportunities to influence positive change.
  • Equal Opportunity Employer practices.
  • Reasonable accommodation available for candidates with disabilities during the application process.
  • Privacy protections for applicant data, including a CA Privacy Notice for California applicants.

Interested in this position?

Apply directly on the company website

Apply Now

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