Safety Governance Lead

3 days ago


Malmo, Skåne, Sweden TFS HealthScience Full time
Role Overview

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We offer full service-capabilities, resourcing and functional service (FSP) solutions.

The QPPV/Safety Manager plays a crucial role in the Project Delivery organization, responsible for management of Drug Safety and adhering to company policies, SOPs and regulatory requirements. Key responsibilities include:

  • Holding QPPV responsibilities for some customers
  • Acting as a Project Manager for Post marketing Safety-only projects
  • Writing safety parts in PSUR/PBRER, RMP other safety documents
  • Literature search
  • Handling of spontaneous adverse event reports from the market
  • Reviewing and approval of processed cases and AE/SAE reconciliation
  • Coding of adverse event, medical history and concomitant medication according to MedDRA and WHO-Drug Dictionary
  • Electronic reporting to EudraVigilance
  • Contributing to plans/instructions and SOPs for post approval surveillance
  • Updating of templates for safety handling in specific studies/projects according to relevant SOPs
  • Participating in relevant meetings
  • Providing internal support to other relevant departments
  • Involved in improvement projects with other relevant departments
  • Actively contributing to the organization and development of routines to enhance the work at TFS
  • Validation of computer applications specific for the department with respect to drug safety requirements
  • Being well-informed and updated on laws, directives and guidelines concerning pharmacovigilance and other safety issues
  • Education and supervision of new Drug Safety personnel
  • Participating in marketing activities

Our team values collaboration, innovation, and making a difference in the lives of patients. If you are passionate about Pharmacovigilance and want to join a dynamic team, apply now



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