Associate Director Safety Risk Management (m/f/x)
Location
Marburg | Germany
Job description
For our Global Clinical Safety and Pharmacovigilance department, we are looking for an
Associate Director Safety Risk Management (m/f/x)
Fulltime / permanent/ non-tariff
R-224246
The Opportunity
As Associate Director Safety Risk Management, located within CSLs Global Clinical Safety and Pharmacovigilance department, you will provide strategic risk management support for CSL products under the direction of the Senior Director Safety Risk Management Lead. You will be responsible for implementing projects and activities related to Safety Risk Management, including procedural enhancements (in collaboration with partner functions), training and awareness measures, strategies, and additional Risk Minimization Measure implementations.
The Role
- One of your main responsibilities will be to lead the development and promotion of Safety Risk Management best practices, processes, tools, and policies to ensure consistent safety risk management excellence across the organization.
- You will guide product teams strategically during the development of risk management planning documents, contributing recommendations for risk management activities, including country-specific PV and risk minimization activities (e.g. educational materials).
- You will provide global support for additional Risk Minimization Activities implementation and tracking, and you will lead enhancement activities for these tracking processes.
- Another focus will be for you to drive the development, review and contribution to safety relevant SOPs and improvement of safety relevant procedures, and to develop materials, that ensure the consistent use of these procedures. You will be accountable for training the organization on Safety Risk Management processes.
- Further on you may drive cross-functional collaboration projects with partner functions to enhance Safety Risk Management processes.
- You will contribute to best-in-class RMPs and support responses to queries from Health Authorities with the highest quality standards.
- As a liaison for in- and external collaborators you will develop programs and processes to meet regulatory requirements and enhance internal processes.
- In this role, you will maintain and share knowledge of evolving global regulatory risk management requirements with relevant functions of the organization.
- In regulatory agency inspections and internal audits you will represent Safety Risk Management, you will address findings related to Risk Management, and will ensure that resultant Corrective Action Plans are implemented efficiently and effectively.
Your Skills and Experience
- University Degree (Diploma or MSc) in Life Sciences (e.g. MD, PharmD, biology, nursing, nutrition), Quality or in related area with relevant experience (Other degrees (e.g. BS, BA) and certifications considered if commensurate with related Pharmacovigilance experience)
- Significant experience in PV across all key PV processes
- 8-10 years of experience in multinational biotechnology or pharmaceutical industry, 5-7 years of experience in Pharmacovigilance/Safety Risk Management, preferably 3 years of experience in GCSP
- Expert knowledge of local/international regulations and PV processes
- Experience with regulatory inspections, administration of complex data sets and relevant software applications
- Experience with project-managing CAPA and SOP development
- Experience in GxP
What we offer
- Innovative work-environment at our R&D; campus
- CSL-subsidized company bike leasing
- Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old)
- Access to Gym facility on campus
- 2 Wellness days per year (additional paid time off)
- Family services such as psychological support, legal advisory, family care services and more for you and your direct family
For more information, please check out our global benefits below.
We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
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