MENA Region: Saudi Arabia, Egypt, Middle East
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.
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