The Opportunity
The Pharmacovigilance & Regulatory Quality Assurance (PVRQA) Regional Lead is responsible for managing, maintaining, further developing and implementing scalable, globally aligned Pharmacovigilance & Regulatory Quality processes across Global Clinical Safety & Pharmacovigilance (GCSP), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA), Affiliates, Commercial Operations as well as other related interface departments on a regional level to ensure that CSLB’s entire Pharmacovigilance (PV) System is in compliance with applicable pharmacovigilance regulations and requirements, GVP, ICH GCP guidelines, respective GxP guidelines, international standards, relevant regulatory requirements and company policies.
The Role
Provide GVP consultancy and other pharmacovigilance regulatory expertise in the Region to support the organization in maintaining required compliance
Efficiently manage and oversee the regional PVRQA budget and head count aligned with global processes and forecasting expectations, including development/mentoring of auditors and support personnel
Provide direction to regional auditors within Global PVRQA in the analysis of audit/ inspection observations, systematic problems and non-compliances.
Ensure efficient PVRQA presence in the region, including profound and efficient interfacing with stakeholder functions in relation to audit and inspection strategies as well as non-compliance trends
Responsible for leading the Quality Assurance preparation, management and follow-up for all PV Health Authority inspections, GMP inspections which involve PV topics as well as 3rd party audits of CSLB’s PV system in the region
Lead and oversee the development, maintenance, execution and completion of the Global PVRQA Audit Program based on the long-term PV Audit Strategy in line with GVP Module IV (PVRQA audits of applicable global systems across GCSP, GRA, GMA and respective interfaces, affiliates and 3rd party vendors) in the Region
Analyze and report inspection and audit observations, gaps and systematic issues to relevant CSL management functions in order to improve processes within GCSP, GRA, GMA as well as affiliates, 3rd party vendors and other interfacing functions.
Responsible for initial qualification of PV service providers in the Region, as well as other GxP service providers as they touch Pharmacovigilance. Ensure processes (including respective KPIs) are in place for a continuous quality oversight of all active service providers in the Region as well as maintenance of the respective qualified service provider list.
Your skills and experience
Preferably, graduate degree in Scientific Discipline/ Life Sciences or related disciplines, or alternatively a bachelor’s degree and significant work experience as below. Global environment experience preferred
Minimum of 10 years of pharmaceutical industry or research/management experience, minimum 6 years’ experience in Pharmacovigilance Quality Assurance or other GxP Quality Assurance experience. Previous experience in managing or participating in regulatory inspections
Extensive experience in GVP regulations and knowledge of international and national regulations and guidelines
Domestic/International Travel (up to approx. 25%) will be required when possible
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.
