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Director of Signal Assessment
vor 3 Monaten
Director of Signal Assessment & Clinical Trial Safety (m/f/d) Global Product Safety
Director of Signal Assessment & Clinical Trial Safety (m/f/d) Global Product Safety
- Full Time
- Leadership Role
YOUR ROLE
As Director of Signal Assessment & Clinical Trial Safety (m/f/d) and a key member of the Product Safety Leadership Team, you will play a vital role in the advancement and success of the Merz Therapeutics organization. Collaborating with your team, you will significantly influence our global clinical studies and actively contribute to the global product development of R&D from a safety standpoint. Your primary responsibilities will encompass the following:
- Lead and nurture a team of six professionals while overseeing the planning and management of the allocated budget.
- Shape clinical development strategies for our neurotoxin and other forthcoming products with a focus on safety considerations.
- Proactively enhance existing processes and design new global (EU and RoW) procedures within your area of expertise.
- Safeguard the integrity of our pharmaceuticals through advanced signal management, including signal detection and evaluation processes for both marketed products and those in clinical trials, by owning the comprehensive safety strategy and ongoing risk-benefit assessments.
- Conduct thorough Health Hazard Evaluations, including risk assessments, categorization, and in-depth evaluations of the medical implications of manufacturing issues and quality deviations that may pose risks to products or patients.
- Ensure the quality and compliance of regulatory documents, such as PSURs, EU Risk Management Plans, and DSURs.
- Assist in the preparation and follow-up of audits and inspections.
- Serve as the primary contact for regulatory inquiries and questions from subsidiaries regarding drug safety.
- Evaluate risks that may arise from quality deficiencies.
YOUR QUALIFICATIONS
- Advanced studies in human or veterinary medicine (preferably with a PhD) or a university degree in natural sciences, complemented by extensive professional experience in product/drug safety.
- Significant professional experience in a research-oriented pharmaceutical company or a Contract Research Organization (CRO).
- Experience in clinical development, ideally including submissions for marketing authorization.
- Strong pharmacovigilance (PV) experience and a comprehensive understanding of PV regulations.
- Proven track record of leading, motivating, and developing a team.
- Proficiency in utilizing safety databases (e.g., ARISg, Oracle ARGUS).
- Excellent command of both German and English.
- Highly independent analytical and conceptual thinking, with a passion for designing and refining processes.
- Structured approach to work with effective time management and a high degree of reliability.
YOUR ADVANTAGES
- Personalized career development in a meaningful role: you enhance the quality of life for our patients.
- Flexible work model that promotes a healthy work-life balance.
- Modern work environment with excellent transport links and a company restaurant.
- Family-owned global business with flat hierarchies and a culture of openness and respect.
- Competitive compensation package with comprehensive social benefits.
- A range of employer-subsidized perks such as Wellpass, Germany ticket, Corporate Benefits, and JobBike.
ABOUT MERZ THERAPEUTICS
Welcome to Merz Therapeutics, a prominent pharmaceutical company dedicated to assisting individuals with movement disorders, neurological diseases, liver diseases, and other health conditions in regaining their quality of life.
We take pride in being a family-owned and value-driven organization that has been committed to meeting the needs of our patients for over a century and is now a global leader in innovation with products available in more than 90 countries.
Our mission is to utilize our products to enhance treatment outcomes for patients worldwide, thereby alleviating the burden of suffering for those affected and their families.
Our unwavering dedication to continuous research and development ensures that unmet patient needs are identified and appropriate treatments are made available.
Join our international and motivated Merz Therapeutics family and contribute to our mission of achieving "BETTER OUTCOMES FOR MORE PATIENTS".
