Global Safety Lead - Formulation Safety Assessments - Bendigo
For our Global Safety and Pharmacovigilance department, we are looking for a
Global Safety Lead - Formulation Safety Assessments (m/f/x)
R-247827
Fulltime / permanent/ non-tariff
As Global Safety Lead - Formulation Safety Assessments you will have global responsibility for medical oversight of selected pipeline and/or products within the assigned therapeutic area(s).
The Opportunity- You will ensure medical standards and processes are in alignment with expectations of manufacturers by internal and external stakeholders including regulators, governmental agencies, payors, physicians, patients and the general public.
- You will serve as a senior medical representative on the cross-functional therapeutic area, development teams and/or post-marketing product teams.
- One of your main responsibilities will be to set technical medical strategies for global projects and therapeutic areas, consistent with functional expectations.
- You will identify potential challenges, risks and roadblocks associated with the global medical strategy and work as a leader in developing solutions to address these, working cross-functionally and inter functionally with other departments.
- You will identify resources and tools necessary to facilitate risks and to implement necessary risk management initiatives and interface with key high-level internal and external stakeholders to contribute to and approve regulatory reports / submissions / queries
- Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.
- Two years minimum experience as a physician in patient care.
- 3+ years pharmaceutical / biotechnology industry experience, with 1 of which include accountability for medical oversight/evaluation or clinical development.
- Industry experience in designated therapeutic area(s).
- Experience and success in addressing and managing complex medical issues in the pre-approval and post-approval environment.
- Excellent income potential and extended benefits
- Two additional leave days for your personal wellbeing
- Family services such as psychological support, legal advice, family care services and more for you and your direct family
- Hybrid working models
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!