Your solution for creating an efficient Pharmacovigilance System
GvP Consulting | Outsourcing Strategy | Business Process Management | Custom Solutions
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More than a decade of experience in clinical research and Pharmacivigilance, extensive expertise in addressing the challenges that a pharmaceutical or biotech company faces in establishing and advancing its pharmacovigilance system. Proficiency in business process management, integration of a PV system after M&A, as well as consulting and project management."
Service Portfolio
Strategic Outsourcing
The delegation of GxP tasks to service providers in the outsourcing process requires a high degree of organisation and monitoring in order to comply with regulatory standards and to maintain sovereignty over its activities as a company. In the area of pharmacovigilance, this applies in particular to the reporting of adverse drug reactions. Effective design of the outsourcing process and monitoring of service providers ensures quality, compliance and efficiency.
PV Alliance Management
The implementation of licensing agreements in the context of PV partner management regularly generates complex regulatory responsibilities that have to be fulfilled in the form of contracts (SDEA, PVA) and delegations. The implementation of licensing agreements in the context of PV partner management regularly generates complex The implementation of contracts with regard to marketing authorisation holder (MAH) obligations must be systematic and efficient.regulatory responsibilities that must be fulfilled in the form of contracts (SDEA, PVA) and delegations.
Organisational Assessment
As an organisation grows or faces foreseeable new challenges, a systematic assessment of its structures is a helpful way to identify potential for improvement and reduce regulatory risks. A view from the outside will help here.
PV Business Process Management
The meaningful organization of all Pharmacovigilance (PV) business processes poses many challenges for rapidly growing organizations. Automating manual tasks and implementing validated systems is a central task for modern pharmaceutical and biotech companies. We can assist in selecting and implementing the right systems, ensuring that a poor analog process does not become a poor digital one.
"I have worked together with Stefan over several years and have gotten to know him as a highly motivated professional, with whom it's a pleasure to work with. Not only a cooperative and pleasant spirit, but a person with a highly analytical, sharp mind who gets to the root of problems, finds solutions and has the ability to take the team with him while striving for and implementing solutions."
Daniel Rehgut
Sr. Clinical Research Associate & CRA Trainer
References and Previous Employers
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