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.
- 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.
Responsabilities include, but are not limited to, the following:
- 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.