Post-Approval Study Manager 1

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Date: May 13, 2024

Location: Budapest, HU

Company: Richter Gedeon Nyrt.

 

Gyere és csatlakozz a 120 éves Richter Gedeon Nyrt. csapatához, Magyarország és a régió meghatározó gyógyszeripari vállalatához!

Alapítónk, Richter Gedeon álma egy sikeres, nemzetközi gyógyszercégről ma is él. Valóra váltjuk minden nap, amikor új hatóanyagokat fedezünk fel, új terápiákat kísérletezünk ki, új gyógyszereket vezetünk be és hagyományos készítményeinkkel együtt, kiváló minőségben állítjuk elő őket, hogy az emberek jobb, teljesebb életet élhessenek a világ minden táján.

 

A Richter Gedeon

Post-Approval Study Manager 1 

munkatársat keres.

 

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

Várjuk jelentkezésedet, örömmel látunk a Richter család legújabb tagjaként!

Apply now »