Regional Safety Officer Benelux
Regional Safety Officer Benelux
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Job Description
The primary objective of the Benelux (Belgium Netherlands Luxembourg) Regional Safety Officer position is to manage the local pharmacovigilance (PV) system(s) in the CSL enterprise (Behring Seqirus and Vifor) ensuring compliance with applicable PV regulations and guidelines as well as corporate and Global Safety & Pharmacovigilance (GSPV) policies. This role is strictly nonpromotional and operates in alignment with the principles of CSLs Global Safety Governance System to ensure maintenance of the companys license to operate.
Responsibilities:
Establishes and maintains local PV systemsin 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.
Ensures comprehensive oversightof all local pharmacovigilance (PV) activities conducted at CSL and establishes a robust framework for assessing potential risks monitoring trends and managing emerging issues.
Maintains close liaisonwith the EU QPPV and IPV Head of Europe. Acts as the local contact person and fulfills the legal requirements in accordance with applicable legislation
Responsible for the establishment maintenance and oversightof local Pharmacovigilance (PV) processes including but not limited to:
- Management of Individual Case Safety Reports (ICSRs) encompassing their handling reporting and followup as well as compliance oversight where applicable.
- Reconciliation of ICSRswith relevant internal stakeholders such as Global Case Management local Quality Medical Information and Sales Force as well as third parties (e.g. distributors Medical Information vendors Organised Data Collection Systems (ODCS) service providers etc.).
- Regular screening of local literature ensuring that all identified safety information is managed in accordance with local and global processes.
- Maintains uptodate informationrelevant for the Pharmacovigilance System Master File (PSMF) or local PSMF as required by local regulations.
- Oversight of the submission statusof aggregate reports (e.g. PSURs) to the relevant regulatory authorities as well as the preparation or contribution to local aggregate reports Risk Management Plans (RMPs) and supporting documents where necessary.
- Implementation of additional risk minimization measures (aRMMs) where applicable.
- PV oversight of local digital and social media channels.
- Ensuring the existence and regular testingof a local PV business continuity plan.
- Documentation of local PV activitiesin appropriate procedures and records.
- Storage and archiving of PVrelated documentsand records in GXP validated repository.
- Conducting local reportability assessmentsand the reporting of signals and urgent safety information to local regulatory authorities as required.
Providing guidance to direct reportson the execution of local PV processes. Acts as a primary point of contact for all PVrelated matters in their territory/region and timely communication and escalation of PVrelevant issues as per established local and global processes.
Responsible for ensuring awareness and compliancewith 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 relationshipswith 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 uptodate understandingof safety profiles of registered and investigational products. Supports and collaborates with crossfunctional teams to identify and investigate safety concerns contributing to the evaluation of product safety risks. Participates 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 oversightof 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 Markets (IPM) team.
Responsible for the management and oversightof thirdparty subcontracted activities maintaining local control and accountability.
Conducts reviews of relevant Quality Agreementswith business partners ensuring pharmacovigilance obligations are incorporated into PVAs as needed in collaboration with GPAA.
Key PV point of contactfor local PV inspection by competent Regulatory Authorities and/or PV affiliate audits in the territory in collaboration with LSOs CSL QPPV GSPV IPV PVRQA and relevant local functions.
Ensures audit/inspection preparation and closeout activitiesincluding the development of a CAPA plan and the close out of any audit/inspection action items.
Responsible as the followup coordinatorfor CAPAs raised and for the close out of audit action items where necessary.
Manages PV training requirementsof 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 adhoc training and monitoring of training compliance.
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Skills and Experience
- Degree in life science nursing pharmacy or other related area; OR Equivalent experience
- Qualification in line with relevant local legislation
- Experience in the pharma industry and knowledge in pharmacovigilance; OR Equivalent experience in line with relevant local legislation
- Good verbal and written communication skills in English
- Fluent in local language(s) of territory
- Travel Requirements: Domestic and/or international
Our Benefits
We encourage you to make your wellbeing a priority. Its 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 highquality 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 inclusion and belonging. Learn more about Inclusion & Belonging at CSL.
Do work that matters at CSL Behring!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
