- Full Time
- Alfred-Wegener-Straße 2, 60438 Frankfurt am Main, Deutschland
- With Professional Experience
- 4/11/24
- 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 German "Stufenplanbeauftragte".
- Tracking and analysis of updates in legal and regulatory PV requirements and the development of implementation initiatives and PV system improvement (PV Intelligence)
- Creating and updating Safety Agreements for the exchange of safety-related information with Merz affiliates, as well as licensing and distribution partners worldwide
- Creation and updating of local and global PV operating procedures and work instructions (SOPs, WIs)
- 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)
- Ideally first experience in pharmacovigilance and understanding of PV legislation in Germany, Europe, and the UK (e.g., AMG, AMWHV, GVP)
- Basic knowledge in the field of Regulatory Affairs for medicinal products is appreciated
- 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 knowlegde 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
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Pharmacovigilance Officer - Frankfurt, Deutschland - Merz Therapeutics
Beschreibung
(Junior) Pharmacovigilance Officer (w/f/d) Global Drug Safety
View job here
(Junior) Pharmacovigilance Officer (w/f/d) Global Drug Safety
Temporary Position for 18 months
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:
YOUR PROFILE
YOUR BENEFITS
Find out more about our benefits here.
ABOUT US
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 .
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