Safety Surveillance Lead
hace 7 días
Company Overview
Daiichi Sankyo Europe is a leading pharmaceutical company with over 120 years of experience and more than 17,000 employees in over 20 countries. We are dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
Job Description
We are seeking an experienced Safety Surveillance Lead - Oncology to support our European headquarters in Munich, Germany. The successful candidate will be responsible for proactive safety surveillance and risk management for assigned clinical studies, working closely with cross-functional teams to ensure the benefit-risk profile throughout the product lifecycle.
Key Responsibilities
- Evaluate safety data from any source to identify potential safety signals and perform safety analysis/evaluation.
- Track safety signals in the global electronic signal tracking tool and contribute to safety action recommendations and communication and risk minimization plans.
- Present assessments to the Safety Management Team (SMT) or other cross-functional teams.
- Collaborate with Clinical Safety Scientist Lead and Product Safety Lead (PSL) to develop materials for SMT/Product-level safety meetings.
- Develop minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs).
- Develop the Safety Management Plan for assigned products.
Requirements
The ideal candidate will have:
- A strong background in clinical safety and risk management.
- Excellent communication and collaboration skills.
- Ability to work independently and as part of a team.
- Experience with safety surveillance and risk management tools.
- Knowledge of regulatory requirements and industry standards.
Compensation Package
We offer a competitive compensation package, including a salary range of €80,000 - €110,000 per annum, depending on experience, plus benefits and a performance-related bonus.
Why Join Us?
Daiichi Sankyo Europe is a dynamic and innovative company that offers exciting opportunities for career growth and development. Our employees enjoy a supportive and collaborative work environment, with access to cutting-edge technology and resources.
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