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Eu Qppv – France

0-2 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 Description: EU QPPV (Qualified Person for Pharmacovigilance)

Company Overview

Excelya, founded in 2014, is a people-centered Contract Research Organization (CRO) committed to excellence in clinical research. With a team of 800 Excelyates, the company aims to become Europe’s leading CRO through its full-service, functional service provider, and consulting models. Excelya collaborates with industry experts to drive scientific, managerial, and human advancements in healthcare.

What We Offer

The EU QPPV will be responsible for implementing and maintaining the Pharmacovigilance (PV) System, ensuring compliance with European pharmacovigilance regulations. This role will be supervised by the Chief Medical Officer (CMO).


Key Responsibilities

Regulatory Compliance

  • Ensure adherence to European pharmacovigilance regulations by implementing and monitoring internal procedures.

Product Safety Management

  • Oversee and supervise drug safety monitoring processes, including collection, assessment, and reporting of adverse events.

Safety Reporting

  • Prepare and validate Periodic Safety Update Reports (PSURs).
  • Continuously assess the benefit-risk profile of products.

Regulatory Liaison

  • Act as the primary contact for regulatory agencies, ensuring clear and effective communication.

Pharmacovigilance Procedures Development

  • Develop and maintain Standard Operating Procedures (SOPs) to support drug safety management.

Training & Awareness

  • Train internal teams on pharmacovigilance requirements.
  • Foster a culture of compliance and vigilance within the organization.

Audits & Inspections

  • Prepare for and support regulatory audits and inspections.
  • Ensure appropriate corrective and preventive actions are implemented.

Risk Management & Monitoring

  • Implement and oversee Risk Management Plans (RMPs) to identify and mitigate potential drug-related risks.

Process Optimization

  • Propose and implement continuous improvements to enhance pharmacovigilance practices and operational efficiency.

Minimum Requirements

Education

  • Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field.

Experience

  • Significant experience in pharmacovigilance within the pharmaceutical industry.
  • Proven experience in regulatory compliance and safety reporting.
  • Previous exposure to interactions with health authorities and regulatory agencies.

Skills & Competencies

  • Strong knowledge of European pharmacovigilance regulations and practices.
  • Excellent project management and organizational skills.
  • Ability to communicate effectively with internal teams and external partners.
  • Strong analytical and problem-solving abilities.

Personal Attributes

  • Attention to detail and a commitment to quality.
  • Ability to work both independently and collaboratively.
  • Adaptable and proactive approach to tasks.

Language Requirements

  • Proficiency in English (written and spoken).
  • Additional languages are a plus.