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Local Qualified Person For Pharmacovigilance (Qppv) Freelancer - Talent Pool

7+ years
Not Disclosed
10 Nov. 21, 2024
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 Title: Local Qualified Person for Pharmacovigilance (QPPV) - Freelance

Company: Parexel

Location: Remote (Select EMEA Locations & Australia)

About Parexel:
At Parexel, we are dedicated to improving the world’s health by providing biopharmaceutical services that support the transformation of scientific discoveries into innovative treatments. With expertise spanning clinical trials, regulatory, consulting, and market access, our commitment is built on a deep conviction in what we do. Our core values include Patients First, Quality, Respect, Empowerment, and Accountability.

Role Overview:
The Pharmacovigilance team at Parexel is seeking experienced Local Qualified Persons for Pharmacovigilance (QPPV) - Freelancers for future projects. This role is remote-based in select EMEA locations and Australia, offering flexibility and the opportunity to contribute to cutting-edge pharmacovigilance practices on a global scale.

Responsibilities:

  • Act as the Local QPPV, ensuring compliance with local pharmacovigilance (PV) legislation in the assigned territory or territories.
  • Oversee the implementation and management of PV systems to ensure safety and compliance with global pharmacovigilance standards.
  • Fulfill all QPPV responsibilities, including overseeing safety case processing, safety reporting, and safety risk management for clinical trials and post-market products.
  • Collaborate with global teams to manage safety data, regulatory submissions, and reporting in accordance with Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) guidelines.

Requirements:

  • Expert Knowledge of local PV legislation in the assigned territory(ies) and experience in the role of Local QPPV.
  • At least 7 years of experience in managing or implementing PV systems, including quality assurance experience.
  • Proven track record in pharmacovigilance across clinical trials and post-market activities, including safety case processing and safety reporting.
  • Extensive understanding of global pharmacovigilance regulations, GVP, and GCP guidelines.
  • Strong experience in safety risk management and working with safety systems and reporting tools.

Why Parexel:
Joining Parexel means working with a team that believes in the transformative power of science and collaboration. As a freelance QPPV, you will play a key role in enhancing patient safety worldwide, contributing to life-changing therapies.

Apply Now: Parexel Careers