* Degree level qualification in a clinical or life sciences related subject.
* Proven project management and organisational skills.
* Five years' experience gained working in clinical research or a closely related field in the commercial (e.g. CRO, Pharma sector) or 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 academic setting.
* Experience in developing vigilance strategies and safety data management.
* 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 Pharmacovigilance role for a sponsor in a commercial (e.g. CRO, Pharma) 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 studies
* Understanding of MedDRA coding
* Familiarity with medical and therapeutic area knowledge terminology
* Understanding of EudraVigilance 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.
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