Highlights:
- With at least 3/4 years experience within Drug Safety you will be responsible for the following:
- Review serious adverse experience (SAE) information received from Investigator sites and adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance
- Perform quality control review of completed individual and periodic safety reports and ensure compliance with regulatory reporting requirements
- Prepare safety data reports for submissions to clients
- Prepare and/or review expedited safety reports for submission to
- Regulatory Authorities• Represent global safety and pharmacovigilance group at project meetings• Assist in compilation of regulatory submissions, i.e., annual reports, periodic safety update reports• Be the safety lead for projects; to include set-up, project management, client liaison• Maintain current knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and pharmacovigilance reporting• Mentor Safety Associates and other members of the global safety and pharmacovigilance group involved in safety data processing
- Having a Bachelors Degree you will have strong client liaison experience.
- Experience of working with Asian clients would be an advantage. You will be given the opportunity to lead the Pharmacovigilance team when necessary and assume project-related responsibilities of a Manager/Director or Supervisor.
- This is an ideal role for those who feel they have gone as far as they can in their current role and are looking for a new challenge within an organisation where you are recognised for your contribution.
- Hays Pharma is a trading division of Hays PLC and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C’s, Privacy Policy and Disclaimers which can be found at hays.com
- For further details on the role and benefits please call Anna on 020 7922 7141 or mailto: anna.crawford@hayspharma.com
Reference: ACEN10098
Closing Date: 30 May 10
Type: Permanent
Salary: 30000 - 40000
Head Office
Hays Pharma Ltd
25-27 Wootton Street
London
SE1 8TG
England
Tel: Tel: +44 (0) 207 922 7100 Fax: Fax: +44 (0) 207 922 7101
Read more: http://www.pharmiweb.com/careers/results.asp?ROW_ID=521500#ixzz0mfLl836r
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