EastHORN Clinical Services in CEE Ltd is a clinical contract research organisation (CRO) serving global pharmaceutical and biotechnology companies in the development of new medicines. The company has operations throughout Central and Eastern Europe. Since starting 12 years ago, we have grown and have established operations in more than 15 countries.

Our international clients value our enthusiastic and flexible approach to meeting their needs and we are growing rapidly. To support our further growth, we are looking for a

Safety Physician / Senior Safety Physician

Job summary:
We are looking for an experienced Safety Physician with at least 3 years’ experience working as a Safety Physician in Clinical Trials within a CRO or Pharmaceutical company. The position involves working on assigned clinical trial projects and interacting with study physicians, clients, external Pharmacovigilance consultants, clinical investigators, project managers, and other relevant specialists during study set up, execution and close out. Experience working within a Safety Database environment is a requirement, and experience working within the Eudravigilance web based environment would also be an advantage.
We are searching for an experienced, ambitious and energetic person, able to undertake challenges in the project, push forward development of the project and function well in the project team.

Key responsibilities include:

  • Medical review of Serious Adverse Events
  • Writing of SAE narratives
  • Medical coding of Adverse Event verbatim terms into MedDRA
  • Triage of SAE cases to determine if they meet the expedited safety reporting requirements
  • Creation of Safety Management Plans
  • Ensuring compliance with necessary reporting timelines
  • Preparation of expedited and periodic safety reports when required
  • Assists client with Registration within Eudravigilance
  • Act as Responsible Person on behalf of the Client in the Eudravigilance environment
  • Perform Eudravigilance SUSAR reporting
  • Enter IMP information into Eudravigilance medicinal product dictionary
  • Follows all new safety reporting requirements
  • Works with external Consultants, as needed

Other responsibilities include:

  • Assurance that pharmacovigilance activities are in line with ICH guidelines/EU regulations
  • Management of software tools needed for pharmacovigilance department function
  • Involvement in proper set up of pharmacovigilance responsibilities for all company projects
  • Knowledge base of local regulations / requirements for safety reporting in relevant countries
  • Advice and training of the company staff on the requirements of safety reporting
  • Assurance of proper and timely safety events processing and reporting
  • Ensuring that assigned project(s) is/are conducted in accordance with applicable regulations, SOPs and Sponsor/Client requirements, within agreed timelines to achieve goals
  • An opportunity to also act as Study Physician/Medical Monitor on studies

Minimum Requirements: 

  • At least 3 years experience as Safety Physician in Clinical trials in CRO or Pharmaceutical Company
  • Medical/Dental Degree obtained at a recognized University
  • At least 2 years experience managing patients in Hospital or General/Dental Practice

Required Qualifications, Experience, Competencies :

  • Knowledge of PhV processes, drug development process, ICH/GCP guidelines and local regulatory requirements
  • Experience in setting-up/conducting clinical trials and evaluation of adverse events
  • Excellent organizational and time management skills
  • Skills to handle multiple priorities and to work with deadlines and under pressure
  • Excellent presentation, written and oral communication skills
  • Excellent client facing interaction skills
  • Fluent in written and verbal English
  • Computer competency
  • EU Based
  • Home or Office Based

Benefits: 

  • Working with experienced and very professional and supportive team
  • Possibility to grow within the Company
  • Competitive remuneration
  • Flexible working time
  • Eligibility to the Company Bonus scheme

If you are a reliable and positive personality and would like to contribute to the further success of a dynamic young company in a growing market, please send your CV and motivation letter in English to: careers@easthorn.eu or complete the form below:

    Apply for job


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