Head of Signal Evaluation and Clinical Trial Safety
vor 2 Wochen
We are seeking a highly skilled and experienced professional to join our team as a Global Product Safety Leader. As a key member of our Product Safety Leadership Team, you will contribute to the development and success of our organization.
About the Role:
- Lead and develop a team of six employees, responsible for planning and managing the dedicated budget.
- Shape clinical development programs for our neurotoxin and other future products from a safety perspective.
- Proactively improve ongoing processes and design new global (EU and RoW) processes within your area of responsibility.
- Ensure the safety of our drugs through state-of-the-art signal management, including signal detection and evaluation processes for marketed products and products in clinical development.
- Contribute to the preparation and follow-up of audits and inspections.
- Contact person for regulatory inquiries and inquiries from subsidiaries regarding drug safety.
About You:
- Studies in human or veterinary medicine (ideally with a PhD) or a university degree in natural sciences paired with several years of professional experience in product/drug safety.
- Several years of professional experience in a research-based pharmaceutical company or in a CRO.
- Experience in clinical development, ideally including submissions for marketing approval.
- Solid pharmacovigilance (PV) experience and a strong understanding of PV regulation.
- Track record of leading, motivating, and developing a team.
- Knowledge of using a safety database (e.g., ARISg, Oracle ARGUS).
- Very good knowledge of German and English.
What We Offer:
- 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.
- 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, Germany ticket, Corporate Benefits, and JobBike.
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 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
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