Safety Systems Project Lead (m/f/x)
Safety Systems Project Lead (m/f/x)
R-246740
Fulltime / permanent/ non-tariff
As Safety Systems Project Lead you will manage and direct functions to comply with standard operating procedures, regulatory safety and pharmacovigilance and business technology quality standards in compliance with national and international regulations, such as relevant GxP guidelines and national and international legislations and regulations as well as aggregate safety reports in area of responsibility.
The Opportunity
- Oversees evolving pharmacovigilance legislations and provides strategic direction for implementation of required changes to the global PV system; this may involve cross-functional approaches, including multiple interface functions.
- Establishes and ensures maintenance of regulatory required documents such as the PSMF, in line with international regulations, guidelines and internal standards.
- Supports the preparation and conduct of PV inspections and audits, as required and organizes or supports the back-office for regulatory PV inspections.
- Oversees/leads signal detection and management processes.
- Implements pharmacovigilance processes and ensures the uniform and timely analysis of safety data.
- Leads or contributes important initiatives to write new processes, or improve/optimize current processes in the functional area; acts as an expert on cross-functional teams for process optimization
- Provides day-to-day management support and direction to direct reports within the functional area.
- Contributes to study activities or post-marketing activities involving safety data and analysis.
- Develops and provides advanced analytical outputs to global teams to support analyses and decision making based on safety data.
- Development of new or enhancement of existing standard reports per company BT quality standards.
- Gathers, details, and documents user requirements in a way that is useful and meaningful to their business area experts and the technical team implementing the solution.
- Analyzes impact from changes to the database or changes in user/reporting requirements and provide guidance for vendors.
- Directs transfer of business requirements into technical solutions.
- Explores, analyzes and introduces data visualization tools to make complex analyses accessible to a broad audience.
- Business Process and/or Inspection SME/Leads for areas of responsibility.
- Provide support related to adverse event reports and ICSR compliance
Your Skills and Experience
- Bachelor degree, Medical Documentation, or equivalent in a life science discipline or Masters (or international equivalent) in science, medicine/health sciences, or epidemiology; or Bachelor degree (or international equivalent) in science, medicine/health sciences, or epidemiology with an increased experience requirement of an additional 3 years industry experience in a related role.
- 8-10 years' Pharmacovigilance experience in multinational pharmaceutical industry.
- 6+ years' experience in a leadership role.
- Expert knowledge of national/international pharmacovigilance regulations and PV processes.
- Knowledge of local/international relevant GxP regulations, IT standards and other relevant legislations such as legislations related to privacy protection.
- Experience with regulatory inspections, administration of complex data sets, project-managing CAPA and SOP development, GxP, and relevant software applications.
What we offer
- 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!
Safety Systems Project Lead (m/f/x)
R-246740
Fulltime / permanent/ non-tariff
As Safety Systems Project Lead you will manage and direct functions to comply with standard operating procedures, regulatory safety and pharmacovigilance and business technology quality standards in compliance with national and international regulations, such as relevant GxP guidelines and national and international legislations and regulations as well as aggregate safety reports in area of responsibility.
The Opportunity
- Oversees evolving pharmacovigilance legislations and provides strategic direction for implementation of required changes to the global PV system; this may involve cross-functional approaches, including multiple interface functions.
- Establishes and ensures maintenance of regulatory required documents such as the PSMF, in line with international regulations, guidelines and internal standards.
- Supports the preparation and conduct of PV inspections and audits, as required and organizes or supports the back-office for regulatory PV inspections.
- Oversees/leads signal detection and management processes.
- Implements pharmacovigilance processes and ensures the uniform and timely analysis of safety data.
- Leads or contributes important initiatives to write new processes, or improve/optimize current processes in the functional area; acts as an expert on cross-functional teams for process optimization
- Provides day-to-day management support and direction to direct reports within the functional area.
- Contributes to study activities or post-marketing activities involving safety data and analysis.
- Develops and provides advanced analytical outputs to global teams to support analyses and decision making based on safety data.
- Development of new or enhancement of existing standard reports per company BT quality standards.
- Gathers, details, and documents user requirements in a way that is useful and meaningful to their business area experts and the technical team implementing the solution.
- Analyzes impact from changes to the database or changes in user/reporting requirements and provide guidance for vendors.
- Directs transfer of business requirements into technical solutions.
- Explores, analyzes and introduces data visualization tools to make complex analyses accessible to a broad audience.
- Business Process and/or Inspection SME/Leads for areas of responsibility.
- Provide support related to adverse event reports and ICSR compliance
Your Skills and Experience
- Bachelor degree, Medical Documentation, or equivalent in a life science discipline or Masters (or international equivalent) in science, medicine/health sciences, or epidemiology; or Bachelor degree (or international equivalent) in science, medicine/health sciences, or epidemiology with an increased experience requirement of an additional 3 years industry experience in a related role.
- 8-10 years' Pharmacovigilance experience in multinational pharmaceutical industry.
- 6+ years' experience in a leadership role.
- Expert knowledge of national/international pharmacovigilance regulations and PV processes.
- Knowledge of local/international relevant GxP regulations, IT standards and other relevant legislations such as legislations related to privacy protection.
- Experience with regulatory inspections, administration of complex data sets, project-managing CAPA and SOP development, GxP, and relevant software applications.
What we offer
- 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!
< Back to list