Drug Safety Manager

Drug Safety Manager

TFS

Warsaw, Poland

Safety Manager, Drug Safety is part of the Project Delivery organization and is responsible for management in Drug Safety/Vigilance and will work according to company policies, SOPs and regulatory requirements.

Key responsibilities:

  • Overall responsibility of the handling of SAE in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the TFS/clients’ SOPs and existing regulatory demands;
  • Review and approval of processed cases, AE/SAE reconciliation and safety coding QPPV responsibilities;
  • Overview of safety activities in the department;
  • Responsible for plans/instructions and SOPs for post approval surveillance;
  • Overlook that assigned projects and tasks in the unit are performed in accordance with current routines, methods, SOPs (TFS or client´s) and current legal requirements;
  • Lead relevant project groups/meetings;
  • Initiate and lead internal improvement project with other relevant departments;
  • Act as a Project Lead for Safety-only projects;
  • Actively contribute to the organization and development of routines/processes to enhance the work at TFS;
  • Responsible for the updates of templates for safety handling in specific studies/projects according to relevant SOPs;
  • Oversees the validation of computer applications specific for the department with respect to drug safety requirements;
  • Ensure that new processes are implemented within the unit;
  • Being well-informed and updated on regulations, directives and guidelines concerning handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues;
  • Line management for staff in the Drug Safety Unit;
  • Coach, support and mentor staff;
  • Responsible for the education and supervision of new Drug Safety personnel;
  • Annual performance reviews with staff including salary negotiating;
  • Approval of time reports and travel expenses;
  • Invoicing/revenue for projects where being a project manager.

Requirements

  • Bachelor’s Degree, preferably in life science or nursing; or equivalent;
  • 10 years of relevant experience;
  • Able to work in a fast-paced environment with changing priorities;
  • Understand the medical terminology and science associated with the assigned drugs and therapeutic areas;
  • Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs;
  • Ability to work independently as well as in a team matrix organization with little or no supervision;
  • Excellent written and verbal communication skills;
  • Demonstrate proficiency using typical word processing; spreadsheets desirable; and presentation software a plus;
  • Demonstrate ability to lead, mentor, educate and supervise Drug Safety personnel.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Poland     Clinical Research     Manager and Executive     Medical     Pharmacovigilance and Medical Information     Quality Assurance     Regulatory Affairs     TFS    

© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies