Senior PV Officer
Stephanie Maccioni is recruiting for a Senior PV Officer to join a Pharmaceutical company at their site based in Hertfordshire on a full time permanent basis.
Our client is a successful consultancy who provide end-end Regulatory and Drug Safety services across the product lifecycle for a wide range of clients.
The role is based at our client's site in Harlow which is easily commutable from London and Hertfordshire, with offices located opposite the train station. Harlow offers everything from arts, culture and theatre to sport, parks and nature reserves.
The Senior PV Officer will support the PV Team Leaders and Management Team in ensuring that day to day operational activities are completed. The Senior PV Officer will be responsible for client management, reviews and checks of aggregate reports and any ad-hoc projects, as required. The Senior PV Officer will be expected to be professional, diligent and liaise with Senior members in the team on any issues. The Senior PV Officer is also expected to lead by example and ensure quality standards are upheld within the company. The activities listed may not always be undertaken by the Senior PV officer, however these activities are within the remit of the role.
Further responsibilities will include:
Knowledge and use of the pharmacovigilance database for processing of Serious Adverse Events (SAE) and Serious Adverse Drug Reactions (SADRs). Triage and QC sign-off of AEs, AESIs, SAEs and SADR reports. Testing for electronic submission via EudraVigilance for relevant Health Authorities as required. Submission of SAEs and SADRs in the appropriate format to the Regulatory bodies, in compliance with the statutory timelines. Compilation and presentation of submission metrics. Organisation of all cases into a comprehensive documentation system.
- Proven experience working in clinical trial pharmacovigilance
- Scientific degree
- Proficient in the use of Microsoft office applications such as Excel, Word and PowerPoint
- An existing demonstrable knowledge of Pharmacovigilance and the regulations governing the field
- CT case management
For more information or to apply for this position, please contact Stephanie Maccioni on 01438 768713 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46244 in all correspondence.