Local Safety Officer/Medical Information - 333

We are looking for a highly skilled and experienced Local Safety Officer (LSO)/Medical Information to join our team. In this role, you will act as a key point of contact for pharmacovigilance (PV) activities in the Benelux region, ensuring compliance with local and international regulations. This position combines responsibilities in local safety management and medical information services, providing vital support to our clients across Belgium, Netherlands, and Luxembourg.

LPPV nominated to authorities, local literature, local regulatory intelligence, local case management and local medical information (30%).

• Act as a Local Safety Officer on behalf of PLG clients in Benelux region, including LPPV nominated to the authorities for Belgium, Netherlands and Luxembourg
• Act as point of contact with local regulatory authorities on a 24/7 basis
• Responsible for notifying local authorities of appointment
• Ensure the continuity of service for the activities inherent to the vigilance responsibilities delegated to PLG
• Responsible for keeping up to date with local regulatory requirements
• To communicate with local authorities and PLG clients professionally and according to given timelines
• Creation and/or Maintenance of local PSMF (as required)
• Support of local PV system, including creation of a local SOPs and agreements Review / update Safety Data Exchange Agreement (SDEA) / Pharmacovigilance Agreement (PVA) / Technical Agreement (TA) as required
• Support/Contribute to local pharmacovigilance (PV) activities performed by the pharmacovigilance /Medical Information line of business in local country
• Liaise with client, affiliate departments and other 3rd party vendors
• To comply with client and PLG policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives
• Contribute/support to the production of client administrative documents, reports and tracking tools
• To participate in audits / inspections and resulting action plan
• Ensure confidentiality and data protection rules are followed, as applicable

Safety information and Medical Information management:

• To perform safety case receipt, processing, translation, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients in the Benelux region, in accordance with agreed timelines, as required
• Perform Local ICSR submissions to local regulatory authorities in Benelux region according to local legislation
• To carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG Clients
• Provision or support of local medical information services (as required)

Local literature and regulatory website monitoring

• Monitoring of Local literature/journal(s) for PLG’s clients products in Benelux Region (as required)
• Perform QC and track activity and results from the literature monitoring
• Assist in selection and review of local journal list when required
• To monitor local Belgium, Netherlands and Luxembourg authority websites for changes in national legislation or safety information relevant for PLG clients
• Tracking of regulatory authority screening and providing results to relevant PLG clients

Other responsibilities (optional):

• Local safety officer coordination – managing projects and teams where local safety activities are outsourced
• Support/oversight of local studies and risk minimisation measures/ activity.
• To perform DSUR, PSUR and RMP translation and submission, as required
• Provision of training to PV stakeholders (sales rep, distributors, affiliate), as required