Senior Drug Safety Officer

Senior Drug Safety Officer

TFS HealthScience

Prague, Czech Republic

Description:

The Senior Drug Safety Officer is part of the Project Delivery organization and will work on handling of drug safety/vigilance issues according to company policies, SOPs and regulatory requirements.

Key responsibilities:

  • Manage 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 demands of the authorities;
  • Review 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;
  • QC and approval of coding of adverse event, medical history and concomitant medication;
  • Review and write the safety section in clinical study protocols;
  • Review of clinical trial reports/IBs from a safety perspective;
  • Write the safety parts in the PSUR/PBRER, DSURs, IND, NDA and other safety documents;
  • Literature search;
  • Electronic reporting to EudraVigilance;
  • Responsible for plans/instructions and SOPs for post approval surveillance;
  • Updating of templates for safety handling in specific studies/projects according to relevant SOPs;
  • Act as a Project Lead for Safety-only projects;
  • Overlook that assigned projects and tasks in the unit are done in accordance with current routines, methods, SOPs (TFS or client´s) and existing demands of the authorities;
  • Participate in relevant meetings. Forward information to relevant members of the department or study team members;
  • Initiate and lead internal improvement projects with other relevant departments;
  • Actively contribute to the organization and development of routines to enhance the work at TFS;
  • Responsible for 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 handling and reporting of SAEs in clinical trials and serious as well as non-serious events from the market (pharmacovigilance) and other safety issues;
  • Education and supervision of new Drug Safety personnel;
  • Participate in marketing activities.

Requirements:

  • Bachelor’s Degree, preferably in life science or nursing; or equivalent;
  • 5 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.

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© EuroJobsites 2022

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

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