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Projektbeschreibung
This company require a PV Officer to join their team on a 6 month basis starting in January.
The successful candidate will have the follwoing experience:
* Case Processing and literature searches
* To discuss when appropriate with sponsor or EU QPPV any issues arising from adverse events reported to PV
* To be aware of and comply with regulations and timelines associated with reporting ADRs/SAEs to competent authorities and ethics committees
* To maintain awareness of current development PV legislation
* To represent the PV department within the company and also at face to face client meetings
* To prepare, review, approve, and submit PV reports and documentation (e.g. SAEs, ADRs, ASRs) within agreed regulatory timelines to achieve clinical excellence
* To carry out all case processing functions relating to Adverse Events and Device Incident
* To maintain tracking systems to monitor compliance to regulatory requirements and SOPs
* To perform literature searching
* To assist with signal detection activities as required
To assist with the preparation of PSURs and other PV documentation as required by clients and competent authorities
If you are interested in this role please contact Jessica Warden-Brown on the contact details below and send an up to date CV for consideration.To find out more about Real please visit www.realstaffing.com
The successful candidate will have the follwoing experience:
* Case Processing and literature searches
* To discuss when appropriate with sponsor or EU QPPV any issues arising from adverse events reported to PV
* To be aware of and comply with regulations and timelines associated with reporting ADRs/SAEs to competent authorities and ethics committees
* To maintain awareness of current development PV legislation
* To represent the PV department within the company and also at face to face client meetings
* To prepare, review, approve, and submit PV reports and documentation (e.g. SAEs, ADRs, ASRs) within agreed regulatory timelines to achieve clinical excellence
* To carry out all case processing functions relating to Adverse Events and Device Incident
* To maintain tracking systems to monitor compliance to regulatory requirements and SOPs
* To perform literature searching
* To assist with signal detection activities as required
To assist with the preparation of PSURs and other PV documentation as required by clients and competent authorities
If you are interested in this role please contact Jessica Warden-Brown on the contact details below and send an up to date CV for consideration.To find out more about Real please visit www.realstaffing.com
Projektdetails
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Einsatzort:
South East England, Vereinigtes Königreich
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung