Post-Approval Study Manager 1

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