Jobbeschreibung
Welcome to Merz Therapeutics, a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life.
We are proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.
Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.
Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.
Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal:
"BETTER OUTCOMES FOR MORE PATIENTS"
For more information, visit https://www.merztherapeutics.com/.
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
·
- Licensed pharmacist or comparable scientific education (e.g. Diploma or Master of Science)
- Experience as Deputy Commissioner of the Graduated Plan and/or Deputy EU/UK QPPV
- Several 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
- Regular further training with regard to current developments in the field of drug safety / PV and Good Pharmacovigilance Practice; experience with the practical implementation of the requirements thereof
- Fluent in written and spoken English and strong communication skills
- Strong analytical skills and ability to work scientifically
- Very careful, conscientious way of working and ability to work in a team
- High level of resilience and self-organization
- Confident handling of Microsoft Office package, if necessary knowledge in handling drug safety databases
-
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.
View More