Job Details

Job Summary:

Join one of the fastest growing CRO's Pharmacovigilance role with career development Clinical Trials and Post Marketing

Requirements:

Due to our continuing growth Chiltern is looking to recruit an experienced Pharmacovigilance Officer. The PVO 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.

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

Qualifications:

• Life Sciences degree
• Relevant experience in CRO industry
• Good knowledge of Global Pharmacovigilance/Drug Safety for Clinical Trials
• Ability to conduct pharmacovigilance activities effectively and efficiently
• Understanding of the principles of ICH GCP and regulatory requirements
• Good computer literacy with working knowledge of Windows and Microsoft Office applications
• Good oral and written communication, organisational skills and personal presentation
• The ability to communicate effectively in English
• Experience working within a team environment under time and resource pressures
• Experience as a Pharmacovigilance Officer or Associate
• Proven experience in clinical trials with knowledge of SOPs, regulatory reporting requirements and accepted practices
• Confident dealing with external and internal clients and providers

Additional Information:

• This is a full time office based role in Slough and may involve travel
  For a confidential discussion about this opportunity, please phone Steven Dilworth on 01753 216 674. To apply, please send your CV to steven.dilworth@chiltern.com
• For more information about Chiltern International, please visit our web site at www.chiltern.com
• Please note that if your experience does not mirror that of our requirements for this role you may not receive a response