YOUR CONTRIBUTION
Join our Pharmacovigilance Group within Global Product Safety and grow with new challenges. Your scope of work with us will include the following tasks:
- As Deputy EU/UK QPPV and Deputy Graduated Plan Officer (“Stufenplanbeauftragter”), you will maintain the oversight of the timely preparation and maintenance of essential documents in the area of pharmacovigilance, such as the PV System Master File, safety reports (e.g. PSURs, RMPs), contractual agreements with license/distribution partners and service providers, work instructions etc.
- Maintaining and shaping the international pharmacovigilance (PV) system for all drugs of Merz Therapeutics including Merz Entities, license/distribution partners and service providers of Merz Therapeutics focusing on maintaining information channels, responsibilities, and work processes in collaboration with the QPPV and the "Stufenplanbeauftragter".
- Accompanying and monitoring of risk and referral procedures and coordination of the resulting measures, e.g. recalls / risk defense
- Active preparation and participation in PV audits and PV inspections and to ensure the implementation of resulting Corrective and Preventive Actions
- Creation and updating of local and global PV operating procedures and work instructions (SOPs, WIs)
- Commissioning and supervision of vigilance service providers for outsourced vigilance activities as well as preparation and updating of the corresponding contracts.
- Creating and updating Safety Agreements for the exchange of safety-related information with Merz affiliates, as well as licensing and distribution partners worldwide
