Head of Signal Evaluation & Clinical Trial Safety (m/f/d)
YOUR CONTRIBUTION
As Head of Signal Evaluation & Clinical Trial Safety (m/f/d) and member of the Product Safety Leadership Team, you contribute to the development and success of the Merz Therapeutics organization. Together with your team of six, you contribute to our global clinical studies and thus actively shape the global product development of R&D from a safety perspective. Your main responsibilities will include the following activities:
- Lead and develop a team of six employees as well as taking over the planning and responsibility of the dedicated budget
- Shape clinical development programs of our neurotoxin as well as 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 by means of "state of the art" signal management including signal detection/signal evaluation processes for marketed products and products in clinical development by owning the overall safety strategy and ongoing risk-benefit assessment
- Ensure the safety of our drugs by thorough Health Hazard Evaluations including risk assessment, categorization and profound evaluation of medical impact of manufacturing issues, quality deviations with potential product or patient risks
- Ensure the quality of regulatory documents, e.g., PSURs, EU Risk Management Plans, DSURs
- Contribute to the preparation and follow-up of audits and inspections
- Contact person for regulatory inquiries and inquiries from subsidiaries regarding drug safety
- Assess risks that may result from quality deficiencies
YOUR PROFILE
-
Studies in human or veterinary medicine (ideally with a PhD) or 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
-
Highly independent analytical and conceptual way of working as well as pleasure in designing and developing processes
-
Independent and structured way of working with good time management as well as a high degree of reliability
YOUR BENEFITS
- 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.
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 https://www.merztherapeutics.com/.
