LSO US and Seqirus NA

Position Description:
The primary objective of the USA Local Safety Officer (LSO) position is to manage the local pharmacovigilance (PV) system(s) in the CSL enterprise (Behring, Vifor, and Seqirus) for the US and applicable US territories, and at the Canadian affiliate for Seqirus if required, ensuring compliance with applicable PV regulations and guidelines as well as corporate and Global Safety & Pharmacovigilance (GSPV) policies. This role is strictly non-promotional and operates in alignment with the principles of CSL’s Global Safety Governance System to ensure maintenance of the company’s license to operate. This leader will be responsible for the following:

• Develop and support local PV systems in compliance with local 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.
• Ensures comprehensive oversight of all local pharmacovigilance (PV) activities conducted at CSL
Responsible for the establishment, maintenance, and oversight of local Pharmacovigilance (PV) processes, including but not limited to:
• Oversight of the submission status of aggregate reports (e.g., PSURs) to the relevant regulatory authorities.
• Contribute to the preparation of local aggregate reports and supporting documents if requested.
• Awareness of local implementation of Risk Evaluation and Mitigation Strategies (REMs), if applicable
• PV oversight of local digital and social media channels.
• Documentation of local PV activities in appropriate procedures and records.
• Awareness of local reportability assessments and the reporting of signals and urgent safety information to local regulatory authorities as required.
• Providing guidance to direct reports on the execution of local PV processes if applicable.
• 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. May provide deputy support across the CSL enterprise for their territory/region when the US LSO Lead is unavailable
• 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), (e.g., for ODCSs), Commercial (e.g., for ODCSs), , Research & Development Quality Assurance (R&DQA) and Clinical.\
• Participates in local Commercial Operations Team meetings as required and provides input into 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.
• Responsible for the management and oversight of third-party subcontracted activities, maintaining local control and accountability.
• Conducts reviews of relevant Quality Agreements with business partners, ensuring pharmacovigilance obligations are incorporated into PVAs as needed in collaboration with GPAA.
• Supports and participates (as required) in local Pharmacovigilance 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 relevant affiliate 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.
Requirements:
• Degree in life science, nursing, pharmacy, or other related area; OR
• Equivalent experience
• Qualification in line with relevant local legislation
• 8+ years in the pharma industry, and knowledge in pharmacovigilance; OR
• Equivalent experience in line with relevant local legislation
• Ability to work effectively and collaboratively across local affiliate functions, the GSPV organization and other CSL functions
• Ability to establish and maintain good working relationships with internal and external stakeholders
• Good verbal and written communication skills in English
• Fluent in local language(s) of territory if required by legislation
• Ability to manage, resolve or escalate issues as appropriate

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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.

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As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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