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Pharmacovigilance (Qppv)

7+ years
Not Disclosed
10 July 1, 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

Job Opportunity: Freelance Local Qualified Person for Pharmacovigilance (QPPV)

Location: Remote positions available in select EMEA locations and Australia

Company Overview: Parexel is dedicated to improving global health by offering a comprehensive suite of biopharmaceutical services. We help clients worldwide transform scientific discoveries into new treatments through clinical trials, regulatory consulting, and market access. Our commitment to quality, patient focus, respect, empowerment, and accountability drives our work.

Role Overview: The Pharmacovigilance team at Parexel is seeking to build a network of freelance Local Qualified Persons for Pharmacovigilance (QPPVs) for upcoming projects. These roles can be based remotely in select EMEA locations and Australia.

Key Responsibilities:

  • Provide expert knowledge of local pharmacovigilance (PV) legislation in the assigned territory(ies).
  • Manage or implement PV systems, ensuring compliance with local and global regulations.
  • Handle all aspects of PV to fulfill the responsibilities of a Local QPPV.
  • Engage in pharmacovigilance safety risk management, including clinical trials, post-market pharmacovigilance, safety case processing, safety reporting, and safety systems.
  • Collaborate with cross-functional teams to ensure high standards of PV compliance.

Qualifications and Experience:

  • Minimum of 7 years of demonstrated experience in managing or implementing PV systems, including quality assurance experience.
  • Documented experience in all aspects of PV to effectively fulfill the role of Local QPPV.
  • Extensive knowledge of global pharmacovigilance regulations, Good Pharmacovigilance Practice (GVP), and Good Clinical Practice (GCP) guidelines.
  • Strong background in pharmacovigilance safety risk management across clinical trials and post-market settings.

Skills:

  • Comprehensive understanding of local and global pharmacovigilance regulations.
  • Excellent organizational and communication skills.
  • Ability to work independently and collaboratively within a global team.
  • Strong analytical and problem-solving abilities.

Why Join Us: At Parexel, we are driven by our mission to improve global health. Our core values—Patients First, Quality, Respect, Empowerment, and Accountability—guide our work and inspire us to make a difference. Join us in transforming scientific discoveries into new treatments and help us deliver better health outcomes for patients worldwide.

If you have the expertise and passion for pharmacovigilance and are looking for an exciting freelance opportunity, we encourage you to apply.