PV Auditor
PV Auditor
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Job Description
This role effectively manages and conducts internal and external (thirdparty) audits to provide independent and objective factbased opinions and to assure compliance with applicable Primevigilance and/or Clients procedures and local and global regulatory requirements as well as contractual agreements.
Role and Responsibilities
Principal Responsibilities:
Conduct audits initiated by PrimeVigilance according to the agreed Audit Plan including effective management of preaudit activities.
Audit types include:
o Audits of PrimeVigilances Partners and Vendors/Service Providers;
o Internal Audits of Projects and Processes
Document audit findings and recommendations and identify process improvement
initiatives and document them in an Audit report in agreed formats and timelines;
Principal Functions and Responsibilities may include but not inclusive of the following:
CoAuditor for full Vendor and Internal System Audits Lead for Full PV Vendor Audits
1 Audit internal
Effective management of preaudit activities: Communication with Auditee preparation of Audit plan Audit checklist etc. in agreed formats and timelines;
Conduct audits initiated by PrimeVigilance in line with agreed Audit plan
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;
Act as Lead Auditor on an assigned audit basis: Manage Audit Team in the performance of audits ensuring that audits comply with applicable PrimeVigilance and/or clients procedures and local and global regulatory requirements as well as contractual agreements.
2 Other Supportive Responsibilities
Participate in workshops or trainings organised by PrimeVigilance and create/develop and present training to PrimeVigilance staff on applicable regulatory requirements;
Qualifications :
. in Science Nursing or related scientific field.
Sufficient experience in pharmaceutical and/or biotech pharmacovigilance with an good understanding of GVPrelated Quality Management and Assurance and adequate GxP auditing experience in an Audit Lead role.
GxP Knowledge: Indepth knowledge of the applicable GxP regulations eg EU and FDA regulations particularly EU GVP
Analytical written and oral communication skills.
Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in preestablished goals and deadlines.
Ability to think strategically and to work collaboratively using riskbased proactive approaches to problemsolving
Strong team player
Good / Strong English language skills (written and spoken) additional languages a plus but not required
Proficiency in all MSOffice applications including Microsoft Word Excel and PowerPoint
Other EDMS e.g. Veeva Vault Master Control Trackwise a plus but not required
Additional Information :
Why PrimeVigilance
We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a humancentric environment where people of all cultural backgrounds genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly supportive working environment
- Opportunity to work with colleagues based all over the world with English as the company language
Our core values are key to how we operate and if you feel they resonate with you then PrimeVigilance could be a great company to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
