Drug Safety Specialist

Albion Rye Associates

  • Brussel
  • € 40.000-45.000 per jaar
  • Vast
  • Voltijds
  • 23 dagen geleden
Job Title: Drug Safety SpecialistLocation: Brussels, Belgium (Hybrid working)Languages Required: Fluent French and Dutch (English is a strong asset)About the CompanyJoin a globally renowned pharmaceutical organization committed to innovation and patient safety. With a strong presence in Belgium and worldwide, the company focuses on delivering high-quality therapeutic solutions across a broad range of therapeutic areas. You'll be part of a passionate team working to ensure that products are safe and compliant throughout their lifecycle.Position OverviewAs a Drug Safety Specialist, you will play a key role in monitoring and evaluating the safety profile of medicinal products. You will manage adverse event reporting and ensure compliance with local and global pharmacovigilance (PV) regulations. This is a highly collaborative role interfacing with local affiliates, healthcare professionals, regulatory authorities, and global safety teams.Key Responsibilities
  • Receive, review, and process Individual Case Safety Reports (ICSRs) from healthcare professionals, patients, and partners.
  • Perform data entry and quality checks in safety databases in accordance with internal SOPs and regulatory timelines.
  • Collaborate with global PV colleagues to ensure timely submission of reports to regulatory authorities.
  • Support the preparation and review of aggregate safety reports (PSURs, DSURs, RMPs).
  • Participate in signal detection and safety review meetings.
  • Monitor local literature and regulatory updates relevant to drug safety.
  • Ensure compliance with local regulations and international guidelines (e.g., EMA, ICH, GVP).
  • Contribute to pharmacovigilance audits and inspections.
Education & Experience:
  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related discipline.
  • Minimum 1–3 years of experience in pharmacovigilance or a regulatory/drug safety-related role.
  • Proficiency in French and Dutch is mandatory; English (written and spoken) is highly preferred.
  • Experience with safety databases (e.g., Argus, ARISg, Veeva Vault Safety) is an asset.
What’s Offered
  • €40,000 - €45,000 with full benefits package (incl. healthcare, pension, meal vouchers).
  • Hybrid working model (home/office balance).
  • International exposure with opportunities for professional development and growth.
  • Dynamic and inclusive work environment in the heart of Europe.
Interested candidates are encouraged to apply with a CV and cover letter highlighting their relevant experience and language capabilities.

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