Local Specialist Safety Officer

2 weeks, 3 days ago
Contract
Entry Level
Operations
Excelya

Excelya

Excelya is a global CRO offering full-service, FSP, and Resourcing solutions to Biotech, Pharma, and Medical Device companies, prioritizing people-first healthcare advancements.

Professional Services
251-1K
Founded 2014

Description

  • Collect, document, forward, follow up on, and report case reports, complaints, queries, and requests within required timelines.
  • Perform local literature searches and reviews, or quality control on review results, and maintain local journal and conference lists.
  • Act as the local contact person or backup contact person for national competent authorities on vigilance issues.
  • Maintain the required understanding of regional and national vigilance legislation.
  • Participate in audits and inspections.
  • Collect and assess local safety information and regulatory intelligence in compliance with applicable local regulations and requirements.
  • Serve as a point of contact for local regulatory authorities regarding pharmacovigilance and other product safety matters.
  • Participate in local and global projects within the Pharmacovigilance and Safety department.

Requirements

  • Minimum 1 year of experience in pharmacovigilance.
  • Ability to meet local and national requirements to act as the local responsible, contact, or qualified person in pharmacovigilance.
  • Life-science degree or relevant degree, or an equivalent combination of experience and education.
  • Fluency in English and Slovenian.
  • Experience working in a regulated pharmaceutical or clinical research environment is advantageous.
  • Familiarity with local and national vigilance legislation is required.
  • Experience supporting audits or inspections is preferred.

Benefits

  • Freelance part-time role.
  • Opportunity to contribute to a dynamic, ambitious team in pharmacovigilance and clinical research.
  • Access to diverse projects through a full-service, functional service provider, and consulting model.
  • Work alongside preeminent experts to broaden scientific, operational, and human knowledge.
  • Inclusive, diverse, equitable, and collaborative workplace.
  • Environment that encourages personal and intellectual growth.
  • Equal opportunities for all employees.
  • Chance to help improve the patient journey and contribute to a meaningful mission.

Interested in this position?

Apply directly on the company website

Apply Now

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