Pharmacovigilance Director

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  • Drug Safety oversight of the UK office
  • Management of international EU Projects
  • Excellent prospects of growth within small/mid sized CRO environment
  • End to end service provider giving a wide scope for skills development

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.

 

Your experience:

 

General:

  • 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.

 

The company:

 

  • 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

 

The Salary:

 

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.