Company: ProClinical Ltd
Closing Date: 27 Oct 16
Salary (£): Competitive
A great chance to join a leader in early clinical research as a Drug Safety Associate at their base in Uxbridge, London. This organisation focuses on the implementation of innovative strategies to generate key data very early, to enable go/no-go decisions in drug development. With a large clinical capacity this is one of the most successful CROs in the world. ...
A great chance to join a leader in early clinical research as a Drug Safety Associate at their base in Uxbridge, London. This organisation focuses on the implementation of innovative strategies to generate key data very early, to enable go/no-go decisions in drug development. With a large clinical capacity this is one of the most successful CROs in the world.
-To assist with and support all local safety related activities as directed by the UK and Ireland Head of Drug Safety
-Ensure compliance with local and international regulations and internal standards.
-To execute timely local case-processing activities, including ensuring robust investigation and follow-up of local safety reports for both marketed products and those under development.
-To assist with timely and accurate reporting to the national competent authorities.
-To contribute effectively as part of the Global Safety network
Role and Responsibilities:
SAE/AE Case Processing
-To ensure the accurate, timely and complete receipt, evaluation and follow- up of domestic adverse event reports.
-To maintain the local archive of safety reports
-To maintain current awareness of local and global safety regulations
-To ensure compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilizing ARISg and E2B.
-To contribute to the development and maintenance of corporate policies, standard operating procedures and associated documents on safety data handling.
Internal affiliate development
-To assist with training of the affiliate organisation and associated third parties on safety data reporting requirements
-To capture, follow-up and ensure the appropriate persons within the company are notified of locally reported Product Quality Complaints.
Skills and Knowledge Requirements:
-Life science/Pharmacy degree or Registered Nurse
-Attention to detail
-Ability to follow standard operating procedures
-Be able to work independently and as part of a team
-Strong identification with the company's values
-Excellent written and verbal communication skills
Leadership Competencies (Behaviours)
-Foster Teamwork-Individual Contributor Behaviors
-Demonstrate Adaptability- Individual Contributor Behaviors
-Promote Open Communication- Individual Contributor Behaviors
-Drive Execution -Individual Contributor Behaviors
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Lisa Edgar on 0203 7520 313 or upload your CV on our website www.proclinical.com. A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Eldon House Eldon Street London
|Tel:||0800 988 4437|
|Fax:||+44 (0)207 834 9470|
|Website:||Visit Our Web Site|
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