EndereçoAre you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas .
Following a new opportunity, we are currently looking for a Pharmacovigilance Auditor responsible for conducting PV audits to suppliers/contractors and willing to support our clients.
As PV Auditor, you will be required to perform PV related audits in your geographical area in relation to all PV activities e.g. system audits, licensing partners and other service providers. You should have substantial experience in the Pharmacovigilance environment, PV auditing and QA processes along with in-depth knowledge of PV regulations and their application globally.
Responsibilities include, but are not limited to, the following :
- Work towards timelines, company and personal objectives set by Clients and PV procedures;
- Prepare and lead/support the conduct of PV audits and regulatory inspections;
- Co-ordinate and document PV audits of processes, systems, projects, sites, including vendors and safety reporting practices according to SOPs and guidelines;
- Ensure appropriate follow-up of audit findings/Quality issues that may arise;
- Review, write and approve audit reports and CAPAs issued by internal and external providers;
- Ensure the Quality Assurance database and any other QA related trackers are maintained and up-to-date to reflect the status of scheduled audits.
Requirements :
- Experience of managing GVP audit and regulatory authority inspections, including hosting the inspection, preparation of inspection responses, CAPA tracking and follow-up;
- Experience of providing QA support for GxP regulatory authority inspections for the PV aspects;
- Management of vendors from Quality perspective;
- Expertise in risk based quality oversight of PV;
- Ability to manage internal and external audits on a global basis;
- Ability to work in a multicultural, international environment and be prepared to travel to auditee offices when safe to do so;
- English language fluency in speaking and writing (at least B2/C1).
Nice to have :
- Experience in monitoring clinical trials
- Experience in Patient Support Programme
- Experience in Market research programme auditing
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Location : Home -Office (Full Remote)
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation . PQE Group gives you the opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world.
If you are looking for a rewarding and exciting career , PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
