 RefNo: SD-DSO-01  Job Title: DRUG SAFETY OFFICER - SLOUGH, BERKSHIRE - PERM WITH GLOBAL CRO Job Description:
- Due to our continuing growth Chiltern is looking to recruit an experienced Drug Safety Officer. The DSO will be responsible for wide variety of duties within our well established group.
- We will be flexible regarding experience and a structured training and development program will be put in place for the successful individual, however, it is imperative you have previous experience of working within Drug Safety in a CRO or Pharmaceutical Organisation in the UK. You must also have the relevant educational background in order to be considered.
- If successful you will work on a high profile 10,000 patient study to start with, however, there is other projects in mind for the future. We would like to bring someone on board to lead, for example setting up the project, liaise with the sponsor, travel abroad to train staff, problem solve issues, come up with a structured plan to aid the smooth running of processing the large number of SAE's. This is a hand’s on role so we will need someone who is happy to help process the SAE's as well as doing the lead tasks. It’s the perfect opportunity for someone wanting to gain career development and hands on project management experience.
- Chiltern is a leading International Clinical Research Organisation with offices across the World. Established in London in 1982, Chiltern International has accumulated extensive experience running clinical trials from Phase I to Phase IV across a broad therapeutic range. Chiltern provides an extensive range of services for both the international and national management of studies.
Primary Duties:
- Attend study meetings
- Review pharmacovigilance aspects for studies
- Write or advise on pharmacovigilance sections for protocols and other documents
- Write and review SAE narratives and CIOMS forms for the pharmacovigilance department
- Provide 24 hour pharmacovigilance coverage for the pharmacovigilance group if contracted on projects on a rota system
- Discuss any issues arising from adverse events reported to pharmacovigilance both internally and with external clients
- Provide pharmacovigilance advice for Chiltern staff and medical department
- Be aware and advise on current pharmacovigilance legislation
- Participate in training sessions and workshops, including presenting reports from any conferences attended
- To perform training for other departments as appropriate
Country or location: UK - London,UK - SouthEast 
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