PURPOSE Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures
PURPOSE Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures
overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient SafetySupports the
documents with the line unit experts in own responsibilityRecognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-upUpload GMP documents into
) Responsible for signal detection and management activities including, including respective documentation and drug safety reports Contributing to risk management activities including preparation and maintenance
und so Kosten einzusparenIdealerweise haben Sie bereits indirekte Direct Reports gehabtSie arbeiten strukturiert, sind ergebnisorientiert und stark in der Kommunikation mit internationalen StakeholdernSie bringen
show support and alignment and look for new businessMaintain strategic alignment with partnersMonitor and report risks in partner relationships and performanceCommunicate changes to the partner program
reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient SafetySupports the Therapeutic Area Head (TAH) by
management activities including, including respective documentation and drug safety reports Contributing to risk management activities including preparation and maintenance of CCDS, labeling document
responsibilityRecognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-upUpload GMP documents into relevant quality electronic systems (e.g. DocStore Condor