within the CRFG co-ordination unit. The Vigilance Officer will
establish and maintain Device Vigilance or Pharmacovigilance processes
that support the activities of the HRB-CRFG as a delate Sponsor in
relation to Clinical Trials and Clinical Investigations, while being
the primary point of contact for queries and issues related to Sponsor
oversight functions. The role will establish safety oversight
processes for clinical trials of medicinal products/medical devices
across all study phases.
Candidates can be based remotely for this role.
* Degree level qualification in a clinical or life sciences related
* Proven project management and organisational skills.
* Five years**Apply on the website**; experience gained working in
clinical research or a closely related field in the commercial setting
(e.g. CRO, Pharma or Medical Device sector) or in an academic setting.
* Must have experience gained working in a vigilance role (Pharmaco or
Device vigilance) for a sponsor in a commercial (e.g. CRO, Pharma or
Medical Device) or academic setting.
* Experience in developing vigilance strategies and safety data
* Excellent communication skills (oral, written & presentation) with
proven ability to work effectively as part of a team.
* Strong leadership and communication skills.
* Self-motivated and able to work independently, showing initiative
and good judgement.
* Good data management and IT skills.
* At least one year experience gained working directly in a vigilance
role (Pharmaco or Device vigilance) for a sponsor in a commercial
(e.g. CRO, Pharma or Medical Device) or academic setting.
* Qualification in Pharmacovigilance or related discipline leading the
development of safety plans and strategies for safety oversight of
clinical study execution
* Postgraduate Qualification in Clinical Research or other Life
Science or engineering-related subject
* Prior experience in Pharmacovigilance of academic-Sponsored clinical
* Understanding of MedDRA and device vigilance coding
* Familiarity with medical and therapeutic area knowledge terminology
* Understanding of EudraVigilance and EUDAMED reporting processes.
* Clinical Research Data Management experience
* Experience working with EDC systems for data capture and design of
Safety Case Report Forms.
* Good Clinical Practice training
We need : English (Good)