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Safety Officer – Greece

1+ years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Remote 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 Role: Safety Officer (Pharmacovigilance)

Location: Greece (Full-time)
Company: Excelya (Contract Research Organization)

Company Overview:

Excelya is a leading CRO based in Paris, founded in 2014. The company has a global team of 900+ experts that provide trial solutions across a broad spectrum of therapeutic areas. Excelya focuses on collaboration at every stage of a project to achieve success.

Excelya’s goal is to become the clinical research leader in Europe, advancing healthcare and research, and helping clients deliver life-changing therapies.

What We Offer:

Excelya provides a stimulating professional environment where team members can contribute their talents, express their full potential, and participate in impactful projects.

 

Main Responsibilities:

Pharmacovigilance and Safety Reporting:

  • Serve as the Local Contact Person responsible for pharmacovigilance activities.
  • Perform local literature search/review or quality control on results and maintain local journal/conference lists.
  • Handle case reports, complaints, and queries, ensuring proper collection, reporting to clients and authorities.
  • Prepare aggregate reports such as PSURs (Periodic Safety Update Reports) and PBRERs (Periodic Benefit-Risk Evaluation Reports).
  • Prepare and update Risk Management Plans (RMP).
  • Assist in managing and monitoring additional risk minimization activities.
  • Communicate with external stakeholders including clients, regulators, and local collaborators.
  • Submit or assist with the submission of vigilance-related documents and reports.
  • Work on various aspects of product safety, including PV system maintenance.

 

Skills & Qualifications:

Education and Experience:

  • Medical Doctor, Licensed Healthcare Professional, Pharmacist, Health or Life Sciences graduate, or relevant degree.
  • At least 1 year of relevant experience in pharmacovigilance, regulatory affairs, medical communications, or clinical research is an asset.
  • Must meet local/national requirements to act as the local responsible/contact/qualified person for product safety (pharmacovigilance, medical device vigilance, or cosmetovigilance).

Technical Skills:

  • Proficiency in MS Outlook, Word, Excel, and PowerPoint.
  • Strong organizational and communication skills.

Other Skills:

  • Ability to handle documents/trackers with attention to detail.
  • Strong sense of responsibility and confidentiality.
  • Ability to multi-task and work as a team player.
  • Self-motivated and able to work independently.
  • Ability to perform as a trainer.
  • Fluency in English (both written and spoken).

Additional Information:

  • This is a full-time position based in Greece.
  • Excellent English language proficiency is required for the role.