The PV Manager is responsible for establishing and maintaining Pharmacovigilance processes in compliance with regulations. This role acts as a point of contact for PV matters, ensures regulatory compliance, manages local PV systems, trains personnel, and participates in strategic planning while collaborating with cross-functional teams.
Your Responsibilities
- Establishes and maintains local PV systems in compliance with national regulations and GSPV policies. Leverages a diverse and robust set of sources including but not limited to regulatory intelligence, continuous improvement initiatives, key performance indicators (KPIs) as well as audit / inspection findings, to evolve and enhance the local PV system.
- Responsible for the establishment, maintenance, and oversight of local Pharmacovigilance (PV) processes
- Acts as a primary point of contact for all PV-related matters in their territory/region, and timely communication and escalation of PV-relevant issues as per established local and global processes.
- Responsible for ensuring awareness and compliance with current PV regulations and guidelines. Oversees the local assessment, communication, and implementation of new or updated PV requirements, including notifying Global of local reporting obligations to ensure the Global Safety Database remains compliant. Provides advice to management and updates controlled documents and platforms to align with evolving regulations.
- Establishes good working relationships with GSPV, Global Regulatory Affairs (GRA) and local functions, such as Local Quality Officer (e.g., for PTCs), Marketing and Medical Affairs (e.g., for ODCSs), Commercial Operations, Research & Development Quality Assurance (R&DQA) and Clinical.
- Maintains up-to-date understanding of safety profiles of registered and investigational products. Supports and collaborates with cross-functional teams to identify and, investigate safety concerns, contributing to the evaluation of product safety risks. Partakes in internal meetings regarding product safety as applicable.
- Participates in local Commercial Operations Leadership Team meetings as required and provides input to strategic planning discussions as needed, ensuring alignment of PV activities with broader organizational objectives.
- Ensures appropriate pharmacovigilance oversight of all Organized Data Collection Systems (ODCS) within the territory, ensuring adherence to relevant processes. Facilitates the implementation of Pharmacovigilance Agreements (PVAs) in close collaboration with the relevant Global Safety and Pharmacovigilance (GSPV) functions and local teams e.g Global Pharmacovigilance Agreements and Alliance (GPAA) and International Partner Market (IPM) team
- Key PV point of contact for local PV inspection by competent Regulatory Authorities and/or PV affiliate audits in the territory, in collaboration with CSL QPPV,GSPV IPV, PVRQA, and relevant local functions.
- Manages PV training requirements of affiliate personnel and personnel of relevant 3rd party service providers, ensuring these personnel are aware of their PV reporting obligations. This includes development of training materials with IPV, delivery of regular and ad-hoc training, and monitoring of training compliance.
Your Experience
- Degree in life science, nursing, pharmacy, or other related area
- Equivalent experience
- Qualification in line with relevant local legislation
- 3+ years in the pharma industry, and knowledge in pharmacovigilance
- Equivalent experience in line with relevant local legislation
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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
CSL Melbourne, Victoria, AUS Office
evel 9 140 William Street, Melbourne, Victoria, Australia, 3000
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