Director of Patient Safety and Pharmacovigilance

Vor 2 Tagen


Stuttgart, Baden-Württemberg, Deutschland ageneo Life Science Experts (Interim Solutions) GmbH Vollzeit
Job Title: Associate Director

At ageneo Life Science Experts (Interim Solutions) GmbH, we are seeking an experienced Associate Director to join our team in a globally leading (bio)pharmaceutical company. The successful candidate will be responsible for orchestrating global initiatives for Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) pertaining to compounds at various stages of development.

Key Responsibilities:
  • Collaborate with the clinical development department to devise patient-centric benefit-risk evaluations for developmental compounds.
  • Work with Global Epidemiology and Medical Affairs to design safety-oriented post-authorization studies.
  • Analyze clinical trial safety data for incorporation into clinical trial reports and regulatory submissions.
  • Provide medical-scientific insights into regulatory documents, including PSURs, DSURs, RMPs, and Clinical Overview Statements.
  • Keep senior management apprised of the safety profile of designated drugs and suggest PV/RM actions.
Requirements:
  • Medical degree with clinical and/or clinical research experience.
  • Excellent English language skills, both written and verbal.

Benefits: global and intercultural work environment



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