YOUR CONTRIBUTION

As (Senior) Manager Signal Evaluation & Clinical Trial Safety (m/f/d) you contribute to the development and success of the Merz Therapeutics organization. Together with your team, you contribute to our global clinical studies and thus actively shape the global product development of R&D from a safety perspective. Additionally, you support the future growth of our company through continuous integration of new assets into our routine safety processes. Your main responsibilities will include the following activities:

• Lead, mentor and develop a team of seven employees and provide guidance to ensure the team`s success
• Shape clinical development programs of our neurotoxin as well as other future products from a safety perspective
• 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 quality of regulatory documents, e.g., PSURs, EU Risk Management Plans, DSUR
• Ensure the safe use of our drugs by continuously supporting to preparation and maintenance of global labelling documents, e.g. CCDS/CCSI
• 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
• Contribute to the preparation, conduct and follow-up of audits and inspections

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:

• Lead, mentor and develop a team of seven employees and provide guidance to ensure the team`s success
• Shape clinical development programs of our neurotoxin as well as other future products from a safety perspective
• 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 quality of regulatory documents, e.g., PSURs, EU Risk Management Plans, DSUR
• Ensure the safe use of our drugs by continuously supporting to preparation and maintenance of global labelling documents, e.g. CCDS/CCSI
• 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
• Contribute to the preparation, conduct and follow-up of audits and inspection