Local Responsible Person for Pharmacovigilance - Australia & New-Zealand

2 hours, 2 minutes ago
Contract
Junior
Operations
Excelya

Excelya

Excelya is a global CRO offering full-service, FSP, and Resourcing solutions to Biotech, Pharma, and Medical Device companies, prioritizing people-first healthcare advancements.

Professional Services
251-1K
Founded 2014

Description

  • Act as the local pharmacovigilance contact for competent authorities and other stakeholders on PV matters.
  • Ensure compliance with territory-specific pharmacovigilance regulations and client procedures.
  • Manage the receipt, follow-up, documentation, and reporting of safety cases, complaints, and queries within required timelines.
  • Perform reconciliations with internal teams and third parties and escalate local safety signals as needed.
  • Collaborate with Regulatory Affairs to support timely submissions to authorities.
  • Organize and deliver training to local partners on pharmacovigilance requirements and agreements.
  • Support and maintain Safety Data Exchange Agreements (SDEAs) and other PV-related contracts.
  • Monitor local pharmacovigilance legislation and provide updates to stakeholders.
  • Contribute local input to the Pharmacovigilance System Master File (PSMF) and maintain audit readiness.
  • Provide activity reports, quality control of local PV documentation, and act as deputy/back-up LRPV when required.

Requirements

  • University degree in Life Sciences, Pharmacy, or a related field.
  • At least 2 years of experience in pharmacovigilance.
  • Experience in global or regional safety roles is preferred.
  • Previous experience as a Local Responsible Person (LRPV/QPPV) in APAC is a strong asset.
  • Strong knowledge of local APAC pharmacovigilance regulations.
  • Proficiency in MS Office.
  • Familiarity with safety databases.
  • Excellent organizational and analytical skills.
  • Strong communication and multitasking skills in a demanding multinational environment.
  • Fluent in English, written and spoken.

Benefits

  • Opportunity to join a dynamic, ambitious team in a growing PV & Safety function.
  • Work within a young health company of about 900 employees aiming to become Europe’s leading mid-size CRO.
  • Access to diverse career opportunities across full-service, FSP, and consulting projects.
  • Opportunity to work alongside recognized experts across scientific and operational disciplines.
  • Environment that values individual talents, encourages growth, and supports professional development.
  • Chance to contribute to improving the patient journey and broader scientific, operational, and human knowledge.

Interested in this position?

Apply directly on the company website

Apply Now

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