Local Specialist Safety Officer – Slovenia

2+ years

Not Disclosed

Slovenia Spain

10 Feb. 10, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Here’s your rewritten job description along with a unique slug:

Freelance Local Specialist Safety Officer – Slovenia

Excelya | Part-Time | Freelance

Excelya, a leading European CRO founded in 2014 and headquartered in Paris, is home to over 900 experts dedicated to delivering innovative clinical trial solutions across multiple therapeutic areas. With a collaborative, one-team approach, we work closely with clients to ensure excellence in regulatory affairs, clinical operations, quality assurance, and strategic development.

Our mission is to drive healthcare advancements by supporting the development of life-changing therapies. At Excelya, we foster a stimulating professional environment where our team members can thrive, develop their talents, and contribute to impactful projects.

We are currently seeking a Freelance Local Specialist Safety Officer (LSSO) based in Slovenia for a part-time role. Fluency in both English and Slovenian is required.

Role Overview

As a Local Specialist Safety Officer (LSSO) within Excelya’s PV & Safety team, you will oversee local product safety matters, including pharmacovigilance, medical device safety, and cosmetovigilance. You will be responsible for compliance with local regulatory requirements, acting as the key contact for Regulatory Authorities on product safety matters.

Key Responsibilities

Ensure compliance with Excelya and client policies, as well as local vigilance regulations.
Maintain proper documentation and tracking of safety-related records.
Operate and monitor the 24/7 safety phone line, ensuring proper functionality and timely escalation of issues.
Collect, document, assess, and report safety-related information, including adverse events, complaints, and queries, within designated timelines.
Conduct local literature searches, quality control, and maintain journal/conference lists.
Serve as the primary or backup contact person for local competent authorities regarding vigilance issues.
Stay updated on changes in local vigilance regulations and inform stakeholders accordingly.
Assist in submitting vigilance-related documents and reports, including translations and quality control where necessary.
Handle external stakeholder communication while keeping internal teams informed.
Support the implementation of local risk minimization measures and communication of new safety information (e.g., Direct Healthcare Professional Communication, Field Safety Notifications).
Report directly or indirectly to the European Union Qualified Person for Pharmacovigilance (EU-QPPV) within the EEA system.

Qualifications & Experience

Degree in Life Sciences or a relevant field, or equivalent experience.
Must meet local/national requirements for acting as a responsible or qualified person for pharmacovigilance, medical device vigilance, or cosmetovigilance.
Prior experience as a Pharmacovigilance Officer, Clinical Research Associate, or Clinical Trial Assistant is an advantage.
Proficiency in MS Outlook, Word, Excel, and PowerPoint.
Strong organizational and communication skills, attention to detail, ability to multitask, and maintain confidentiality.
Ability to work both independently and as part of a team.
Fluent in English and Slovenian.

Join Excelya and contribute to transforming the future of clinical research!

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Local Specialist Safety Officer – Slovenia

Job Description

Freelance Local Specialist Safety Officer – Slovenia

Role Overview

Key Responsibilities

Qualifications & Experience

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