Data állások Németországban (minőségbiztosítás)

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

• Maintain and further develop our QMS in line with EN ISO 13485 and MDSAP
• Create, update, and improve procedures, forms, and training materials
• Plan and deliver training on procedures and regulatory requirements
• Lead and oversee CAPA initiation, processing, tracking, and review

• Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company's research interest.
• Give insights into clinical data sets and evidence for our company's products to internal stakeholders.

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
• Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy

• Drive and complete reimbursement applications for the Vibrant product portfolio
• Build and check health economic models that clearly demonstrate product value by using appropriate software tools

Lead technical investigations for customer complaints and product CAPAs assigned to R&D, evaluate technical issues that occur during daily use of our systems in hospitals and act as key reference within the R&D team...

• Author, own and maintain internal guidance and training documentation
• Collaborate with various functions within the global company, internal and external suppliers and with customers with the objective to share expertise and provide guidance