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Senior Operations Specialist

£Generous Salary + Benefits | Ireland |  Clinical Research, PV CRO |  Permanent  | Ref:888637



Alice Smith

Which team do you work in?

Clinical Operations

Which area do you specialise in?

Recruiting Clinical Trials professionals 

How do you keep up-to-date with the issues in your sector?

Speaking to candidates and clients on a daily basis allows me to keep up-to-date with changes and news in my industry. I also find LinkedIn groups and professional journals are invaluable for keeping on top of industry topics. 

What's your favourite film and why?

Tim Burton's Big Fish has to be my go-to film of choice. An over the top, fantastical and emotional story of epic proportions full of weird and quirky touches...escapism at it's finest!

If you could invent one thing what would it be?

If I could invent one thing it would be to make the Replicator from Star Trek a reality - I love food but hate cooking after a busy day in the office so this would be ideal! 

What makes you #DistinctlyDifferent?

Having studied art I like to think I look at things with a creative twist and have the ability to look beyond the obvious. This is helpful when it comes to guiding and advising candidates and clients to overcome potential problems and arrive at the best conclusion for all. 






The Role

Senior Operations Specialist - Drug Safety - Global CRO, Europe, £Generous Salary benefits


The Company

I am working with a leading Global CRO seeking a Senior Operations Specialist to join their growing Drug Safety Team in state-of-the-art modern offices in Dublin.

  • Global CRO with a highly regarded international reputation for high-quality work and innovative healthcare development
  • Joining a close-knit and supportive company culture, where performance and initiative are recognised and rewarded
  • World Class reputation for developing market leading products within a multitude of therapy areas
  • List of employee benefits including performance related incentive scheme, pension scheme, private medical insurance, private dental insurance, life assurance and discount scheme (childcare vouchers, gym membership, retail discounts)
  • Ongoing personal development and structured career progression


The Role

As a Senior Operations Specialist within Drug Safety you will be joining a diverse and multi-lingual team based in Dublin to carry out a diverse and challenging role, where you will:

  • Complete submissions to Regulatory Authorities, Ethics Committees, investigator sites, customers, licensing partners and marketing authorisation holders based on approvals of clinical trials and authorisations for specific drugs
  • Review, assess and manage all drug Safety data relating to clinical trials and post marketing studies
  • Manage and update internal systems and databases to ensure all information is stored correctly and producing complex reports
  • Liaising with internal and external contacts to ensure enquiries are handled in an effective and safe way
  • Follow strict GCP, GVP guidelines and SOPs



To be considered for this Senior Operations Specialist position within Drug Safety. You should have:

  • Previous CRO experience within drug safety and regulatory board submissions
  • In depth knowledge of drug safety processes across a variety of clinical stages
  • In depth knowledge of a variety of clinical research GCP and ICH guidelines and SOPs
  • Excellent communication skills and the ability to liaise with clientele at all levels
  • Strong administrative skills and an eye for detail
  • Life Sciences Degree
  • 3 years experience of Drug safety including PV, CEVA, Medical Information, Safety Publishing, Risk Management


What should you do next?

This Senior Operations Specialist role within Drug Safety is a great role and won't be around for long! So don't delay. If you are unsure and need some advice, give me a ring, otherwise just click apply, upload your CV and send, it's really that easy!

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there. Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

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