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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 the 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

 

YOUR PROFILE

  • Studies in human or veterinary medicine (ideally with a PhD) or university degree in natural sciences
  • Several years of professional experience in product/drug safety research-based pharmaceutical company or in a CRO
  • Experience in clinical development, ideally including submissions for marketing approval
  • Expertise in medical writing of e.g. safety signal assessments or regulatory documents, e.g. PSURs, RMPs
  • Strong background in GVP and regulatory requirements Track record of leading, motivating and developing a team
  • Good knowledge of using a safety database (e.g. ARISg, Oracle ARGUS)
  • Very good knowledge of English, German is an advantage
  • Highly independent analytical and conceptual way of working as well as pleasure in designing, developing and optimizing 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
  • 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 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/.

 

Viktoria Becker Talent Acquisition Partner