Pharmacovigilance Specialist
vor 4 Wochen
Merz Therapeutics is seeking a highly skilled Global Pharmacovigilance Expert to join our team. As a key member of our Pharmacovigilance Group, you will play a crucial role in maintaining and shaping our international pharmacovigilance system.
Key Responsibilities:- Maintain and update the Pharmacovigilance System Master File (EEA/UK-PSMF)
- Organize and perform internal and external pharmacovigilance trainings
- Creation and updating of local and global PV operating procedures and work instructions (SOPs, WIs)
- Creating and updating Safety Agreements for the exchange of safety-related information with Merz affiliates, as well as licensing and distribution partners worldwide
- Commissioning and supervision of vigilance service providers for outsourced vigilance activities as well as preparation and updating of the corresponding contracts
- Monitoring of risk and referral procedures and coordination of the resulting measures, e.g. recalls / risk defense, in alignment with responsible functions
- Active preparation and follow-up of PV audits and PV inspections and to ensure the implementation of resulting Corrective and Preventive Actions
- Degree in natural science or pharmacy (e.g., Diploma or Master's)
- 5 years of experience in pharmacovigilance and understanding of PV legislation in Germany, Europe and the UK (e.g., AMG, AMWHV, GVP)
- Knowledge in the field of Regulatory Affairs for medicinal products is necessary
- Willingness to engage in ongoing training for current drug safety practices and GVP implementation
- Confident handling of Microsoft Office package, if necessary knowledge in handling drug safety databases
- Fluent in written and spoken English & good knowledge of German
- Strong communication skills and ability to work in a team
- Strong analytical skills and ability to work scientifically
- Very careful, conscientious way of working
- High level of resilience and self-organization
- Individual career development in a purposeful job: you improve the quality of life of our patients
- Hybrid work model that allows a good work-life balance
- Attractive location with good transport links, modern workplaces and a company restaurant (€3.80/menu)
- Global family business with flat hierarchies and an open, respectful corporate culture
- Attractive remuneration with extensive social benefits
- Variety of employer-subsidized benefits such as Wellpass (€17.90/month), Germany ticket (10€/month), Corporate Benefits and JobBike
Find out more about our benefits here.
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