Pharmacovigilance Specialist
vor 1 Monat
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
- Create and update local and global PV operating procedures and work instructions (SOPs, WIs)
- Develop and maintain Safety Agreements for the exchange of safety-related information with Merz affiliates and partners
- Commission and supervise vigilance service providers for outsourced vigilance activities
- Monitor risk and referral procedures and coordinate resulting measures
- Prepare and follow-up on PV audits and inspections
- Degree in natural science or pharmacy
- 5 years of experience in pharmacovigilance and understanding of PV legislation in Germany, Europe, and the UK
- Knowledge in Regulatory Affairs for medicinal products
- Willingness to engage in ongoing training for current drug safety practices
- Fluent in written and spoken English and good knowledge of German
- Strong communication and analytical skills
- Individual career development in a purposeful job
- Hybrid work model for a good work-life balance
- Attractive location with good transport links and modern workplaces
- Global family business with flat hierarchies and an open corporate culture
- Attractive remuneration with extensive social benefits
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