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Pharmacovigilance Manager

  • V.M.D.
  • Arendonk
  • Onbepaalde duur
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Pharmacovigilance Manager

  • V.M.D.
  • Arendonk
Onbepaalde duur, Voltijds

Pharmacovigilance Manager

Functieomschrijving

Orion Animal Health is seeking to hire a Pharmacovigilance Manager to join our Quality Management team. In this role, you will be managing new pharmacovigilance projects and support the current team in coordinating the daily operations, under the supervision of the QPPV. As a Pharmacovigilance Manager, you will lead efforts to ensure the safety and efficacy of Orion’s veterinary medicinal products by managing pharmacovigilance activities and ensuring compliance with regulatory requirements. Your responsibilities will include overseeing the full lifecycle of pharmacovigilance cases, from data entry and assessment to preparing detailed safety reports, as well as conducting literature surveillance and supporting signal management to identify and evaluate potential safety concerns. You will also play a critical role in maintaining and improving the Pharmacovigilance System Master File (PSMF) and ensuring that all procedures and documentation meet industry standards. Collaborating closely with Quality Assurance (QA), Regulatory Affairs, and Sales, you will facilitate seamless communication and contribute to the continuous improvement of safety monitoring processes. Key Responsibilities of the role include: Pharmacovigilance Case Management
  • Process incoming safety data and manage data entry
  • Perform initial assessments and coding of Adverse Drug Reactions and Events
  • Manage reporting to Competent Authorities and follow-up of cases
Literature Surveillance:
  • Search and screen global and local literature
Signal Management:
  • Conduct safety monitoring and signal detection activities
  • Support the preparation of Signal Management Annual Statements and Benefit-Risk Assessments
Procedures, Documentation, and QMS
  • Develop and update risk management plans, SOPs, work instructions, and maintain the Pharmacovigilance System Master File (PSMF)
  • Streamline and automate existing workflows
  • Manage regulatory procedures
  • Prepare Pharmacovigilance Data Exchange Agreements and support audits and inspections

Profiel

  • A Master’s degree in Veterinary Medicine or Life Science,
  • Fluent in English and French. Preferably also in Dutch. Any other languages will be a plus.
  • Good knowledge of industry principles of Pharmacovigilance, with Minimum 2 years of Proven experience in Pharmacovigilance
  • Excellent stakeholder management & communication skills
  • You are open to change and drive continuous improvement. To this end you Stay current with relevant industry developments affecting veterinary medicinal products.
  • Affinity with EudraVigilance tools (e.g., EVV, Data Warehouse, UPD, IRIS) and Veterinary Good Pharmacovigilance Practices (VGVP).

Aanbod

We offer you versatile, interesting and challenging responsibilities in a multi-professional and international environment. You will be part of a great team with skilled and highly motivated colleagues. Appreciation of colleagues and continuous development are part of our core values. You will have the chance to grow your skills, learn new things, and improve your strengths. We offer a supportive working environment and development opportunities.
Functietype:
Standplaats
Vereisten
Master (Licentiaat; Universiteit of Hoger Onderwijs Lange Type) Nederlands, Engels, Frans
Bron:
VDAB

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