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Local Specialist Safety Officer – Slovenia

0-2 years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Part Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Local Specialist Safety Officer (LSSO)

Location: Slovenia (Part-time, Freelance)
Company: Excelya (Contract Research Organization)

Company Overview

Excelya is a leading Contract Research Organization (CRO) based in Europe, established in 2014, with a global team of over 900 professionals. We are dedicated to delivering life-changing therapies through collaboration across various therapeutic areas. Our vision is to achieve new advances in healthcare and research, working with clients to transform the future of medicine.

Role Overview

Excelya is seeking a Local Specialist Safety Officer (LSSO) based in Slovenia, responsible for handling local product safety issues in the pharmacovigilance, medical device, and cosmetovigilance domains. The role involves ensuring compliance with local regulations, acting as the point of contact for local regulatory authorities, and collecting and assessing safety information.

Responsibilities

Safety and Regulatory Compliance

  • Follow Excelya and Client policies, procedures, and guidelines for product safety.
  • Maintain an understanding of regional/national vigilance legislation and regulatory requirements.
  • Ensure compliance with data privacy requirements according to local and international regulations.
  • Act as a 24/7 safety phone line operator, ensuring the system functions properly and escalation of issues when necessary.
  • Collect, document, forward, follow-up, and report all case reports, complaints, and queries within required timelines.

Data Management & Quality Control

  • Perform local literature searches/reviews and quality control on results.
  • Maintain various tracking systems (e.g., adverse event, query, complaints, journal lists, etc.).
  • Ensure quality control of vigilance-related documents and translations (if applicable).
  • Review and submit vigilance-related documents and reports, ensuring timely submissions and follow-ups.
  • Assist with the reconciliation of cases and local communication of new safety information (e.g., risk minimization measures, Direct Healthcare Professional Communications).

Regulatory Liaison & Communication

  • Serve as the primary contact for local competent authorities on vigilance issues.
  • Monitor changes in local vigilance legislation and inform both external and internal stakeholders.
  • Handle communications with external stakeholders (clients, regulators, collaborators), ensuring proper information flow and collaboration with Safety Project Leaders.

Safety Risk Management

  • Assist with or handle the implementation of local risk minimization measures.
  • Assist in local communication of safety information and implementation of educational material or Field Safety Notifications.

Education & Experience

Qualifications

  • Degree in Life Sciences or equivalent education/experience.
  • Meet local/national requirements for performing as a local responsible/contact/qualified person for product safety (pharmacovigilance, medical device vigilance, or cosmetovigilance).
  • Experience in pharmacovigilance or related fields (e.g., clinical research) is an asset.

Skills & Competencies

  • Proficient in MS Outlook, Word, Excel, and PowerPoint.
  • Strong organizational and communication skills with attention to detail.
  • Ability to manage multiple tasks, work independently, and as a team player.
  • Fluency in English and Slovenian (both written and spoken).

Additional Information

  • This is a freelance, part-time role with Excelya, based in Slovenia.
  • Excellent knowledge of English and Slovenian is required for this role.