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Are you an experienced Pharmacovigilance professional with a background in managing and mentoring a Drug Safety team? Are you ready to take the helm of the Head Office of a quickly expanding UK CRO? Zest Medical welcomes applications on behalf of their client - a high performing & niche company - who are keen to employ a Pharmacovigilance Director to take on oversight responsibilities of their head office, and assist in the expansion activities planned for the future.
- 5+ Years’ experience in Pharmacovigilance / Drug Safety
- A life sciences degree or other relevant academic qualifications
- Background in leadership positions within the Pharmaceutical / Biotechnology / CRO / Healthcare Consultancy fields
- A keen listener with cross functional management experience
- Strong commercial focus, experience of previous client interaction and ideally Business Development Activities (not essential to be considered, but preferable)
Practical Working knowledge of:
- Leadership of a Drug Safety Team
- Management of a portfolio of EU clients
- Preparation of Individual Case Safety Reports (ICSRs) and other relevant documentation
- Creation of Risk Management Plans and Periodic Reports
- SOP review and process improvement
- Leadership of Regulatory Inspections, Safety Reviews and PV audits
- Competent MedDRA coding experience
- Understanding of aggregate report writing (e.g. DSURs, PSURs/PBRERs and PADERs)
- Assessment of Adverse Reaction Reports for potential signal detections
- Representation of the company at client led meetings
- Supervision of the UK office and joint oversight of international activities with the CEO
Previous roles may include: Director of Pharmacovigilance, Associate Director of Pharmacovigilance, Associate Director of PV, Associate Director of Drug Safety, Associate Director of Risk Management, Senior Drug Safety / Pharmacovigilance Manager, PV Project Manager, Medical PV Manager, QPPV Etc.
- A small/medium sized CRO, operating internationally with multiple offices across the globe
- Enjoying a period of fantastic organic growth (20% year on year for the past 4 running)
- An admirable office environment, with a friendly culture and importance placed on team work
In order to obtain the services of the best talent in the sector, our client is willing to be flexible on salary.
Zest Scientific is working to a strict deadline on this position, so please send your CV now and it will be reviewed in confidence immediately.