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South Korea


Pharmacovigilance Auditor

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job at pqe

Due to a constant growth, PQE is looking for a new Pharmacovigilance Auditor - responsible for conducting PV audits to suppliers/contractors, within designated Quality Auditing areas and willing to support us for project activities in South Korea.

    Responsabilities include, but are not limited to, the following:
  • Prepare and conducting GVP audits to suppliers/contractors
  • Conduct audits in accordance with PQE standard operating procedures and clients' directives
  • Escalate immediately to PQE and Clients' Management any critical compliance issues.
  • Communicate audit results immediately to PQE and Clients' Management.
  • Timely document the audit through a comprehensive audit report.
  • If required, manage post-audit activities by reviewing and following up on the auditee CAPA plan.
  • Coach and supervise junior auditors, if requested.
  • Degree in Life Sciences
  • At least 3 years of experience in various roles within pharmacovigilance within the pharmaceutical industry, government agency or a PV consultancy organization
  • Audit and /or QA experience is mandatory
  • Knowledge of GVP regulation as well as 21 CFR and other applicable regulations
  • Excellent knowledge of and experience with pertaining international and local PV legislation, guidelines and directives and able to assess the impact of changes in your areas of expertise;
  • Availability to travel domestically and abroad (at least 50%)
  • Excellent use of major productivity SW (e.g.: MS Office)
  • Good communication and interpersonal skills
  • Client-oriented, dedicated, flexible, able to manage timelines and prioritize your work
  • Fluent English (at least B2/C1 Level) both in speaking and writing
  • Any knowledge of a second language will be considered a plus.

On Demand / Freelance Job

If interested, please send your resume in English, clicking on this page.
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.

job at pqe