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Pharmacovigilance Governance Officer

2-5 years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time 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

What We Offer:

Join a dynamic and ambitious health company on its path to becoming a clinical research leader in Europe. With our 800 dedicated Excelyates, we provide a unique, one-stop service model combining full-service, functional service provider, and consulting. This allows our team members to grow through diverse projects in collaboration with leading experts, enhancing scientific, managerial, and human knowledge to improve the patient journey.

We provide a stimulating professional environment where personal, intellectual, and operational contributions are encouraged. We are committed to empowering each Excelyate to express their natural talents, develop their full potential, and make a meaningful impact on our unique project.

Key Responsibilities:

  • Support the execution of activities such as handling local products and PBER reporting.
  • Manage quality systems, including deviations using Sanofi’s QualiPS tool and updating quality documents.
  • Oversee vendors and manage the AEGIS tool.
  • Handle case management and HA submissions.
  • Manage aRMM distribution, including organizing and participating in CFT (Cross-Functional Team) meetings. Follow up with Medical & Commercial teams.
  • Draft aRMM in accordance with local labeling requirements.
  • Coordinate PSPV training, send training notifications, follow up with personnel, and conduct phone calls.
  • Report directly to the Country Safety Head.

Minimum Requirements:

  • Master’s Degree or Pharmacist’s Diploma in Pharmacovigilance.
  • 2 to 5 years of experience in all safety-related activities within the pharmaceutical industry or CRO.
  • Proficiency in English is required.

Join Excelya today, where excellence in care meets innovation.