This role will support the Vice President of Pharmacovigilance with a range of key activities including Processing and Reporting of SAEs / ADRs, Literature review, Quality Control activates, business development, and Safety Database administration. The ideal candidate will have the desire and capability to develop their skills further, with our support, to act as Deputy EU QPPV, and long term EU QPPV.
This fantastic opportunity has arisen due to investment and expansion, to play a significant role within Pharmacovigilance within Quanticate, a global leading data dedicated Clinical Research Organisation. With an established track record across Data Management, Programming, Statistics, and Medical Writing; the organisation is now looking to develop its PV capability further as part of its global growth strategy.
Based in Hitchin, the role will support the Vice President of Pharmacovigilance with a range of key activities including Processing and Reporting of SAEs / ADRs, Literature review, Quality Control activates, business development, and Safety Database administration. The ideal candidate will have the desire and capability to develop their skills further, with our support, to act as Deputy EU QPPV, and long term EU QPPV.
Essential Experience
* Extensive experience working across all areas of Pharmacovigilance in both clinical trials and post-marketing phases.
* Experience gained working within the field of Pharmacovigilance from within a CRO, Pharmaceutical, or Regulatory sectors.
* A strong understanding of the role of an EU QPPV.
* Experience of Quality Management aspects of Pharmacovigilance including SOP development, and participation in audits and inspections.
* Excellent communications skills in English, both written and verbal.
* Eudravigilance trained and certified by the European Medicines Agency.
To be successful in this role it is likely that you will have a wide knowledge of industry standard safety database systems, including proficiency in the use of Oracle Argus as an administrator and end user. Also, you will need to have an excellent understanding of scientific and medical terminology.
For more information about this role, or to apply, please click apply now, or contact David Jolley on 01462 477 938.