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Local Qualified Person For Pharmacovigilance (Qppv)

7+ years
Not Disclosed
10 July 25, 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, 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

About This Role

Company: Parexel
Location: Remote (select EMEA locations and Australia)

Parexel is dedicated to improving global health by providing comprehensive biopharmaceutical services that help clients turn scientific discoveries into innovative treatments. Our services span clinical trials, regulatory consulting, and market access, driven by a deep commitment to our core values: Patients First, Quality, Respect, Empowerment, and Accountability.

We are seeking to build a network of Local Qualified Person for Pharmacovigilance (QPPV) freelancers for upcoming projects.

Key Responsibilities:

  • Expertise in Local Legislation: In-depth knowledge of local pharmacovigilance (PV) legislation in the assigned territories where the individual will act as the Local QPPV.
  • Experience in PV Systems Management: A minimum of 7 years of proven experience in managing or implementing PV systems, with a background in quality assurance.
  • Comprehensive PV Knowledge: Extensive experience across all aspects of pharmacovigilance, ensuring compliance and effective management of PV responsibilities as a Local QPPV.
  • Regulatory Knowledge: Profound understanding of global pharmacovigilance regulations, Good Pharmacovigilance Practices (GVP), and Good Clinical Practices (GCP) guidelines.
  • Safety Risk Management: Experience in safety risk management, covering clinical trials, post-market pharmacovigilance, safety case processing, safety reporting, and safety systems.

This role offers the flexibility of remote work, with opportunities available in select EMEA locations and Australia. If you are passionate about advancing global health and have the required expertise, we invite you to join our network and contribute to our mission of transforming scientific discoveries into life-saving treatments.