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1-1Recruitment have an opportunity for a Periodic Reports Co-ordinator to join our client’s pharmaceutical company local to Erl Wood, Windlesham. The position is initially temporary for 12 months with the potential to be extended.
The purpose of the Periodic Reporting Coordinator is to support the Surveillance Group within Global Patient Safety in the planning, preparation, submission and archival of periodic reports within the timelines outlined by the Regulatory Authorities.Main duties; ·Collaborate with Quality and Operations to develop procedures concerning periodic calendaring, submission and other associated periodic regulatory tasks·Prepare and maintain the Periodic reports calendar ensuring all amendments are communicated to the relevant teams in a timely manner·Distribute Periodic reports in a timely manner to ensure on time submission to regulatory agencies and/or Ethics Review Board Committees·Provide Periodic report metrics as requested ·Data collection for safety periodic reports from information sources such as RAPT, IMPACT, Business Object (BO) outputs·Perform tasks such as pre- and post-authoring administrative support for periodic report preparation using document management system·Serve as data steward for documentum management system, including accounts & training·Communicate effectively with business partners internal & external·Have an understanding of the role and responsibilities of the EU Qualified Person ·Ensure support of the EU Qualified Person to fulfil his/her legal responsibilitiesThe correct candidate; ·Excellent technical/computer skills including document management systems and other databases·Have strong admin skills/ experience·Excellent organisational skills·Problem solving ability·Attention to detail·Effective communication skills and ability to interact with diverse groups and individuals·Ability to work within a team and independently·Must be willing to complete a DBS/ background clearance 1-1 Recruitment is one of the leading recruitment agencies for jobs in Winchester for permanent, temporary and contract recruitment solutions. Due to the high volume of applications we are receiving, if you do not hear from a consultant within 5 days, unfortunately your application has been unsuccessful on this occasion. In the meantime please keep an eye on www.1-1recruitment.co.uk for any other potential vacancies.