The Local Safety Specialist acts on behalf of PLG clients in the Benelux region (Belgium, Netherlands, Luxembourg), ensuring full compliance with local and international pharmacovigilance (PV) regulations. This role serves as a key local contact for regulatory authorities and supports the delivery of high-quality safety and medical information services in line with client and PLG requirements.

Group 10
Responsibilities:

Local Safety & Regulatory Responsibilities

  • Act as Local Safety Specialist and LPPV (as applicable) for PLG clients in the Benelux region
  • Serve as 24/7 local point of contact with regulatory authorities
  • Notify local authorities of appointments and ensure regulatory compliance
  • Maintain up-to-date knowledge of local Belgium, Netherlands, and Luxembourg PV regulations
  • Ensure continuity of local vigilance activities delegated to PLG
  • Communicate professionally with regulatory authorities and clients within agreed timelines
  • Create and/or maintain local Pharmacovigilance System Master File (PSMF) where required
  • Support and maintain the local PV system, including development of local SOPs and agreements
  • Review and update SDEA, PVA, and Technical Agreements (TA) as needed
  • Liaise with clients, affiliates, and third-party vendors
  • Support audits and inspections, including preparation and follow‑up of action plans
  • Ensure compliance with confidentiality and data protection requirements

Safety Information & Medical Information Management

  • Perform safety case receipt, processing, translation, QC, tracking, and ICSR follow‑up
  • Submit local ICSRs to relevant authorities in the Benelux region according to local legislation
  • Conduct periodic reconciliations to ensure proper handling of safety reports
  • Provide or support local medical information services, as required

Literature & Regulatory Intelligence Monitoring

  • Monitor local literature and journals relevant to client products in the Benelux region
  • Perform QC of literature monitoring activities and track results
  • Support selection and review of local journal lists
  • Monitor Belgium, Netherlands, and Luxembourg regulatory authority websites for relevant safety or legislative changes
  • Track regulatory screenings and communicate results to PLG clients

Group 12
Experience:

Education

  • Bachelor’s or Master’s degree in Medicine, Pharmacy, Nursing, or a life‑science related field, or equivalent experience

Experience

  • 5+ years of pharmacovigilance experience
  • Strong knowledge of Benelux and international PV regulations
  • Experience acting as a local PV contact in the Benelux region (preferred)
  • Hands‑on experience with local PV case management, including receipt, translation, submission, and follow‑up
  • Audit and inspection experience
  • Experience in literature and regulatory website monitoring (preferred)
  • Project management and client‑facing experience

Languages

  • French and Dutch: Native and/or fluent (written and verbal)
  • English: Excellent written and verbal fluency
  • German: Desirable

Technical & Professional Skills

  • Strong organizational and interpersonal skills
  • Ability to work independently and within a team
  • Excellent time‑management and prioritization skills
  • High attention to detail and process‑oriented mindset
  • Proficient in MS Word and MS Excel

Local Safety Specialist (Benelux Region) - VAF 500

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