Regional Safety Officer Benelux

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 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.

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.

Ensures comprehensive oversight of 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 liaison with 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 oversight of local Pharmacovigilance (PV) processes, including but not limited to:

• Management of Individual Case Safety Reports (ICSRs), encompassing their handling, reporting, and follow-up, as well as compliance oversight where applicable.
• Reconciliation of ICSRs with 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 up-to-date information relevant for the Pharmacovigilance System Master File (PSMF) or local PSMF as required by local regulations.
• Oversight of the submission status of 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 testing of a local PV business continuity plan.
• Documentation of local PV activities in appropriate procedures and records.
• Storage and archiving of PV-related documents and records in GXP validated repository.
• Conducting 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.
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.
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 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 Markets (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.

Key PV point of contact for 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 close-out activities including the development of a CAPA plan and the close out of any audit/inspection action items.

Responsible as the follow-up coordinator for CAPAs raised and for the close out of audit action items, where necessary.

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.

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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