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• Cover the PRRC role when requested from the needs of the company (e.g. during the absence of the current PRRC)
• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

• Preparation of analytical evaluation protocols
• Data evaluation (internal / external performance data) by using statistical tools
• Preparation of performance study reports
• Support the post-marked performance follow-up process
• Support the creation of templates for Clinical Evidence requirements

Head of Digitalization & CSV (m/w/d)...

• Provide direct line management for >10 CP Delivery Managers embedded across drug programs and AI/ML model development initiatives
• Build delivery capability through coaching, role clarity, performance management, and career development

Global Scientific Manager - IBU Critical Care Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced...

• 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

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)...