Share this Job

Post-Approval Study Manager

Apply now »

Date: Jan 23, 2022

Location: Budapest, HU

Company: Richter Gedeon Nyrt.

Join us

The Post-approval Study Manager is responsible Preparation of post-authorization study projects, including, but not limited to, objective, risk analysis, project planning and provider selection. Implementation of post-authorization study projects, including, but not limited to, work organization, preparation of necessary documents, monitoring, coordination and reporting tasks.

Your responsibilities will be

  • Preparation, conduct and completion of post-approval studies in close cooperation with the CRO and study teams
  • Carrying out post-authorization studies aimed at detecting and confirming evidence of the company’s products and treated patients
  • Liaise with subsidiaries, trading partners, service providers and other GR departments
  • Ensure information sharing related to any post-approval studies planned or conducted by affiliates
  • Establish and maintain close cooperation between GMD scientific units with regional medical, local trade and regulatory organizations

You bring to our team

  • Supporting the strategy for Pharmacovigilance activities, generating the necessary data, using Real World Evidence (RWE)
  • Supporting of the design, modification and if necessary, interim analysis of post-approval studies (eg NIS, Phase IV, RWE, PASS, PAES) with methodological knowledge
  • Preparation of quality assurance documents (standard operating procedures, working instructions). Participation in educational activities
  • Coordinate, review and prepare RWE projects.
  • Preparation of Post-approval, NIS and RWE studies for approval
  • Independently makes professional decisions in projects. Continuously evaluate the relevant aspects and changing circumtances in order to perform the tasks optimally

We offer

  • Extensive benefits package (cafetera, stock program, private life insurance, to see more, click on the link)
  • Training and development opportunities
  • Medical services (Medicover) 
  • Various sport and health opportunities (gym, swimming pool, AYCM)
  • Challenging, responsible professional work
  • Long-term employment in an innovative and secure workplace