Description
* Represent the GCO Safety Unit in audits and provide support during inspections
* Ensure that systems used by the GCO Safety Unit for outbound safety reporting are up-to-date and validated
* Ensure that processes are documented and reviewed
* Ensure reconciliation and compliance monitoring activities
* Monitor and ensure adherence to global regulatory requirements and relevant procedures
* Act as key contact for various stakeholders related to outbound safety reporting
* Support clinical trial teams with the set-up of compounds and trials in the safety reporting systems used by the GCO Safety Unit for the distribution of outbound safety reports
* Provide guidance and training to the clinical trial teams related to outbound safety reporting processes
* Implement Service Agreements with local operating companies
Your profile
* University degree (preferably life sciences)
* At least 3 years' experience in the Pharmaceutical Industry, with at least 2 years' experience in safety reporting or clinical research
* Demonstrated strong organizational, interpersonal and communication skills and experience of working in cross-functional teams, in an international environment
* Effective decision-making and problem-solving skills, in order to address safety and compliance issues in a timely manner
* Understanding of the broader impact and possible implications of safety and compliance issues
* Ability to work accurately to tight timelines
* Excellent German and English language skills (written and spoken)
* Excellent computer skills, MS Office Suite, ideally knowledge of system life-cycle management and validation
