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Specialist Clinical Safety

1+ years
Not Disclosed
10 May 22, 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

Job Title: Specialist Clinical Safety
Category: Quality
Locations: Lisbon, Portugal | Madrid, Spain | Sofia, Bulgaria
Job Type: Full Time
Posted Date: April 24, 2025
Job ID: R256776


About Cencora:

At Cencora, people are the center of our mission to create healthier futures. Each team member plays a crucial role in our journey. If you want to contribute to meaningful change in global health, join our dynamic and rapidly growing organization.


Job Description:

As a Specialist in Clinical Safety, you will be part of the Pharmacovigilance (PV) team, supporting clinical safety activities across multiple programs. This role offers a unique opportunity to grow within the PharmaLex brand and make a tangible impact on patient safety, especially within the pre-authorization phase of drug development.


Key Responsibilities:

  • Manage and monitor SAEs, AESIs, and pregnancy cases throughout the safety reporting lifecycle

  • Communicate with relevant stakeholders and follow up for pending information

  • Perform initial triage for seriousness and expectedness of reported events

  • Enter case data into safety databases

  • Prepare narratives and assist with case quality control (QC) alongside Safety Manager

  • Generate and maintain Line Listings (LLs) and Development Safety Update Reports (DSURs)

  • Ensure timely safety submissions and maintain trackers and administrative documents


Skills Required:

  • Team player with a service-oriented mindset

  • Excellent organizational and multitasking abilities

  • Ability to analyze and assimilate information quickly

  • Strong sense of responsibility and self-motivation

  • Adaptable and flexible in a fast-paced and evolving environment

  • Proficient in spoken and written English

  • Clear and effective communication skills


Qualifications & Experience:

  • Bachelor’s degree in medical, natural sciences, or pharmacy-related field; Degree in Medicine also accepted

  • Minimum 1 year of relevant experience in Pharmacovigilance

  • Familiarity with safety databases (preferably Argus or Safety Easy)

  • Experience in case management and pre-authorization pharmacovigilance


What Cencora Offers:

  • Comprehensive benefits tailored to local market practices

  • An inclusive and equitable workplace

  • Commitment to equal employment opportunities

  • Support for individuals with disabilities through reasonable accommodations during the hiring process


Affiliated Company: PharmaLex Spain S.L.U.
📧 For accommodations:
hrsc@cencora.com
📞 Or call: 888.692.2272
🖥️ Visit:
www.cencora.com