Director Global Safety (m/f)

REFERENZNUMMER:

310448/9

IHRE AUFGABEN:

-Medical evaluation and regulatory assessment of serious adverse events from clinical trials
-Ensure compliance in case processing according to internal timelines and timely reporting to authorities, Ethics committees and other stakeholders
-Compilation of Development Safety Update Reports (DSURs) and IND Safety Update Reports
-Approval of international scientific marketing material
-Organization of the safety management in clinical trials in collaboration with Contract Research Organisations (CROs) and Global Vigilance
-Medical Review of and input to the safety-relevant sections of Case Report Forms, Informed Consent forms and Study Protocols
-Training on GCP, guidelines and regulations
-SAE reconciliation

IHRE QUALIFIKATIONEN:

-Physician with profound clinical experience in internal medicine, anaesthesia or similar speciality
-Long-term experience in pharmacovigilance with knowledge in both clinical development and post marketing surveillance, including experience in risk management programs, crisis management etc.
-In-depth understanding of safety databases and PV workflow and processes
-Very good knowledge in international pharmacovigilance rules and regulations
-Fluency in German and English (spoken and written)

WEITERE QUALIFIKATIONEN:

Drug safety manager