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Local Contact Person for Pharmacovigilance and Regulatory Affairs

πŸ•’ yesterday
PharmacovigilanceRegulatory AffairsRisk ManagementADR Reporting

πŸ“œ Description

  • Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance
  • Provision of local regulatory intelligence screening and expert advice for the responsible region(s)
  • Collection and reporting of locally suspected ADRs or ICSRs
  • Local management of risk minimization measures related to safety issues
  • Support with development and implementation of local pharmacovigilance system

πŸ› οΈ Requirements

  • Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
  • At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or regulatory environment
  • Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical exposure)
  • Experience in case handling, literature screening, or local PV activities is preferred
  • Prior experience in Regulatory Affairs is preferred but not mandatory
  • Proficiency in English and additional language knowledge is advantageous
  • Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint
  • Prompt and effective communication with MAH and local regulatory authorities as required
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The RA & PV specialist ensures compliance with national pharmacovigilance and regulatory requirements in Australia, acting as the primary local representative for these activities.

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