RemoteLeaf Logo
Log in Sign up

Drug Safety Lead

1 hour, 57 minutes ago
China
Full-time
Lead
Program Manager
Project and Program Management
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 54

Description

  • Interface with sponsors, vendors, and internal teams to design and implement safety collection tools, processes, and reporting systems.
  • Participate in the assessment and setup of safety databases to capture serious adverse event data.
  • Manage serious adverse event and SUSAR case handling from intake through regulatory reporting.
  • Review, prepare, and approve safety budgets and related budget tasks.
  • Prepare and review project-specific safety reporting plans, medical coding plans, and safety training materials.
  • Develop and maintain standard operating procedures and work instructions.
  • Serve as a subject matter expert for the department and provide safety expertise to clients, sites, and team members.
  • Provide training and mentorship for Safety Specialists.
  • Participate in audits, audit preparation, investigator meetings, and kick-off meetings.
  • Support CAPA management, bid defenses, resource oversight, and departmental initiatives.
  • Lead safety standalone projects and cross-functional development activities.
  • Generate and track SAE/AESI queries and support escalation and resolution efforts.
  • Review and help prepare responses to regulatory agency questions related to safety and pharmacovigilance.
  • Assist clients and internal staff with safety-related reviews and other services.

Requirements

  • BA/BS degree.
  • 10+ years of clinical safety experience.
  • 5+ years of pharmacovigilance experience.
  • Health care 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 safety reporting requirements in clinical trial environments.
  • Experience supporting internal audits, inspection readiness, and regulatory inspections, including BLA or NDA approval inspections.
  • Excellent written and oral communication skills and strong analytical ability.
  • Ability to communicate complex clinical issues clearly and scientifically.
  • Ability to work in a fast-paced, innovative environment with flexibility and efficiency.
  • Early phase oncology clinical trial experience is preferred.

Benefits

  • Opportunity to work on groundbreaking cancer therapy programs.
  • Employee contributions are appreciated and ideas are valued and nurtured.
  • Role offers the chance to impact positive change within a growing organization.
  • Equal Opportunity Employer workplace.
  • Reasonable accommodations available for candidates with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Oklo

Fuels Licensing Manager

Oklo 51-250 Electric Utilities

Oklo is hiring a Fuels Licensing Manager to support licensing and regulatory work for its advanced nuclear fuel fabrication and recycling technologies in close coordination with engineering teams and the U.S. nuclear regulator.

United States Full-time Senior Compliance Manager Program Manager
$50k-$166k
12 minutes ago
Remote

Payroll Lead, Implementations - Denmark (Nordics)

Remote 251-1K Professional Services

Remote is hiring a Global Payroll Country Lead for the Nordics to support payroll implementation work, with a primary focus on Denmark, across its fully remote international team.

Europe Denmark Full-time Senior Payroll Specialist Program Manager
$45k-$101k
SAP
12 minutes ago
Valtech

Senior Service Manager

Valtech 5K-10K Professional Services

Valtech is hiring a Senior Service Manager in Poland to oversee operational support and service excellence for large international clients within a global, cross-functional delivery environment.

Poland Full-time Senior Program Manager
Agile Kanban Scrum
27 minutes ago
Jensen Hughes

Lead Consultant - Energy Storage & Advanced Electronics Safety

Jensen Hughes 1K-5K Construction & Engineering

Jensen Hughes is seeking a Lead Consultant in the San Diego, Anaheim, or Los Angeles area to manage and expand energy storage system engineering services across office, client-site, and remote work settings.

United States Full-time Lead Business Development Program Manager
$111k-$172k
27 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers