Pharmacovigilance Compliance Manager
A vacancy has arisen for a Pharmacovigilance Compliance Manager with an internationally renowned pharmaceutical company, based in their UK office. This organisation is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organisation and support their innovative impact on the healthcare field. This will be a 12 month contract, ideally based in Cambridge for at least 3 days per week, but candidates for the company's Stockley Park office will also be considered.
- Managing and leading routine and complex PV audits, including internal processes, vendor, and affiliate audits.
- Writing audit execution plans.
- Writing audit reports.
- Communicating audit findings.
- Conducting risk assessments.
- Reviewing responses to audit reports to determine acceptability of proposed CAPAs.
- Performing CAPA verification by reviewing of objective evidence.
- Evaluating internal and vendor reported non-compliance and approving CAPA plans.
- Writing CAPA effectiveness methodology.
- Performing CAPA effectiveness checks.
- Undertaking reviews of internal Procedural Documents.
Skills and Requirements:
- A degree in a Life Sciences field.
- 8+ years of relevant experience (relevant work experience consists of working as a pharmacovigilance auditor and/or in a pharmaceutical quality assurance environment).
- An in-depth knowledge of global pharmacovigilance requirements.
- Experience with TrackWise is advantageous.
- Ability to travel (nationally and internationally) to conduct on-site audits (minimum of one audit trip abroad each month).
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Ronni Hartgen at +44 2038000814 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.