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Specialist Clinical Safety

1+ years
Not Disclosed
10 April 30, 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

Specialist – Clinical Safety
Category: Quality
Employment Type: Full Time
Posted Date: April 24, 2025
Job ID: R256776
Location: Remote (Spain)
Company: Cencora (PharmaLex Spain S.L.U.)


About the Role:

Cencora is seeking a motivated and enthusiastic PV Specialist to join its Clinical Safety team under the Pharmalex brand. This is a remote-based opportunity ideal for individuals looking to make a meaningful difference in global health through pharmacovigilance activities.


Key Responsibilities:

  • Manage Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and pregnancy reports.

  • Communicate with all necessary parties and ensure timely follow-ups for pending case information.

  • Perform initial triage, including assessment of seriousness and expectedness of SAEs.

  • Enter data into safety databases.

  • Write case narratives.

  • Support Safety Manager with case reviews in the safety database (QC).

  • Prepare line listings and maintain annual safety reporting plans and distribution lists.

  • Handle safety submissions and maintain case trackers and administrative documentation.


Skills Required:

  • Strong teamwork and organizational skills.

  • Ability to multitask, analyze information rapidly, and manage responsibilities independently.

  • High sense of responsibility, flexibility, and adaptability.

  • Service-oriented mindset.

  • Proficient in English (written and spoken).

  • Excellent communication skills.


Experience & Educational Background:

  • Bachelor’s degree in medical, natural sciences, pharmacy, or a degree in Medicine.

  • Minimum 1 year of experience in pharmacovigilance, specifically in case management.

  • Familiarity with safety databases (preferred: Argus, Safety Easy).

  • Experience in pre-authorization and clinical safety environments.


What Cencora Offers:

  • Benefits aligned to local market practices in Spain.

  • Commitment to equal employment opportunity and reasonable accommodations for individuals with disabilities.