Pv/mi Officer
4 days ago
Pharmacovigilance/Medical Information Officer for a fast-growing Consultancy (office or UK remote)
An expanding Life Sciences consultancy with 3 offices across the UK are now searching for a Drug Safety/MI Officer to join their close-knit team. This is an opportunity that will provide you with a lot of exposure, valuable knowledge, growth and progressionwith the company. You will be surrounded by very experienced and likeminded individuals.
The Company:
This consultancy focuses on delivering high quality advisory and outsourcing solutions that cover the full product life cycle, from concept through to launch and post-market, offering a great depth of variety. They specialise across the Life Sciences spectrum,namely pharmacovigilance, medical information, quality assurance, regulatory affairs, product development, project management and more. As they are a smaller sized company, your role will not be restricted and will provide much variety - if you are lookingfor exposure in any particular area, it is absolutely accessible. They are renown for their flexibility in pushing your career in the direction you see fit and have proven examples of fast-track progression and excellent training/development.
The PV/MI Officer role:
Your main responsibilities may include (but are not limited to):
- End-to-end case management (clinical and post market)
- Working cross functionally and issuing technical support in both PV and MI
- Providing high-quality support to the EEA/EU QPPV
- Providing a high-quality service to clients
- Cross-collaboration with other departments and internal and external stakeholder management
- Benefit risk assessment strategy
- Participating in signal management activities
- Audit and inspection activities / CAPA management
- Quality review and routine compliance checks
- Act as PV SME in meetings
- Training and mentoring
- Monitoring he medical information inbox and informing management of safety issues
- Logging, tracking and providing summaries
You:
- A good pharmacovigilance background/experience/knowledge (ideally a consultancy, though CRO/pharma is fine)
- Understanding of GVP and GDP
- Excellent communication and a proactive approach
- Be driven, ambitious and enthusiastic
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