Senior Auditor - Pharmacovigilance / Drug Safety
For our sister company PrimeVigilance who shares values and offices with us, we are looking for a Senior Pharmacovigilance Auditor to join PrimeVigilance´s global team of professionals making a contribution to the health of people around the world.
The PV Auditor will be responsible to effectively manage and conduct internal and external (third-party) audits to assure compliance with applicable PrimeVigilance´s and/or Client´s procedures and local and global regulatory requirements as well as contractual agreements.
- Effective management of pre-audit activities: Communication with Auditee, preparation of Quality plan, Audit plan, Audit checklist, etc. in agreed formats and timelines;
- Conduct pharmacovigilance audits initiated by PrimeVigilance, according to the agreed Audit Programme and in line with agreed Audit plan and Quality plan:
- Audits of Partners and Service Providers;
- Audits of Projects and Activities.
- Conduct Audits of Third Parties (TP) on behalf of Clients in line with agreed Audit plan and Quality plan and Client´s specification;
- Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines;
- Plan, create and maintain Corrective and Preventative Action Plans if needed, on an assigned audit basis;
- Generate and monitor audit metrics and performance evaluation.
- Act as Lead Auditor on an assigned audit basis: Manage Audit Team in the performance of pharmacovigilance audits, ensuring that audits comply with applicable PrimeVigilance and/or client´s procedures and local and global regulatory requirements as well as contractual agreements.
- Support audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities;
- Participate in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of PrimeVigilance and/or Client as per operational needs;
- Keep up-to-date about the relevant regulations, legislation of Pharmacovigilance, participate in relevant seminars and trainings;
- Participate in workshops or trainings organised by PrimeVigilance and create/develop and present training to PrimeVigilance staff on applicable regulatory requirements;
- Perform other activities as required by the company management in the area of responsibilities and qualifications as stated above.
Qualifications and Skills:
- University education in life sciences or healthcare
- Strong experience in Pharmacovigilance
- Previous auditing experience
- Knowledge of EU and FDA Regulations as well as Guidelines on Good Pharmacovigilance Practice (GVP) and ICH Guidelines
- Advanced knowledge of standard 19011:2011 and its principles, rules, key points, ethics and objectives, would be a plus,
- Quality-oriented, quality-committed
- Excellent interpersonal and communication skills, including good presentation and report writing skills
- Meticulous attention to detail
- Self-motivation, determination and confidence in own abilities
- Ability to work to deadlines, under pressure
- Ability to work on your own initiative and as part of a team
- Fluent knowledge of English; additional languages would be a plus.
If you feel that you have the right background combined with the right attitude, we would be delighted to receive your application with a structured CV. Please contact us on firstname.lastname@example.org.