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Senior 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: Senior Specialist Clinical Safety
Category: Pharmacy & Clinical
Location: Oslo, Norway
Job Type: Full Time
Posted Date: May 1, 2025
Job ID: R258122


About Cencora:

At Cencora, our people are the foundation of our mission—to create healthier futures. Every individual plays a vital role, and we pride ourselves on fostering an environment where innovation, compassion, and commitment thrive. Join us and help improve lives across the globe.


Job Description:

We are currently hiring a Senior Specialist Clinical Safety to join our growing team in Oslo, Norway. This role is crucial in supporting clinical safety operations, focusing on case processing, literature review, regulatory documentation, and quality oversight in alignment with pharmacovigilance standards.


Key Responsibilities:

  • Enter and quality-check Individual Case Safety Reports (ICSRs) from clinical trials, spontaneous reports, and literature

  • Report ICSRs to relevant regulatory authorities

  • Generate and track follow-up requests for additional safety data

  • Screen scientific literature for safety-relevant publications and maintain accurate documentation

  • Assist in preparation of PSURs, DSURs, PADERs, Risk Management Plans, and signal detection documentation

  • Participate in client meetings, project discussions, and daily safety operations

  • Maintain the Pharmacovigilance System Master File (PSMF)

  • Contribute to quality assurance documentation including SOPs, WIs, and templates

  • Assist in internal and external audits/inspections

  • Train new team members on pharmacovigilance activities

  • Take on cross-functional responsibilities across service lines and project management where needed


Skills and Competencies:

  • Strong team player with excellent organizational and multitasking skills

  • High level of responsibility, motivation, and service orientation

  • Flexible and adaptable to evolving demands

  • Fluent in written and spoken English

  • Excellent communication skills, both written and verbal


Qualifications:

  • Bachelor’s degree in medical, pharmaceutical, or natural sciences—or a Degree in Medicine

  • Minimum 1 year of professional experience in pharmacovigilance

  • Familiarity with safety databases (e.g., Argus, Safety Easy)

  • Hands-on experience in case management

  • Previous exposure to pre-authorization pharmacovigilance activities


What Cencora Offers:

  • Benefits aligned with local market practices (may vary based on location and collective agreements)

  • Supportive work environment with access to growth opportunities and training

  • Equal opportunity employer committed to non-discriminatory practices

  • Reasonable accommodation available upon request during the employment process

Affiliated Company: PharmaLex Norway AS
📧 Accommodation requests:
hrsc@cencora.com
📞 Contact: 888.692.2272