« Home
0

applicants

Clinical Safety Manager Full Time

at Barrington James London in London (Published at 03-08-2021)

Clinical Safety Manager


Job Type: permanent
Sector: PVG and Drug Safety
Job Category: PVG and Drug Safety
Region: Europe
Area: England Scotland
Location: Unspecified
Posted: 3rd August 2021

My client a leading global CRO are looking for a Clinical Safety Manager to join their diverse, collaborative and inclusive Safety team. The Clinical Safety Manager will lead & contribute to the ongoing co-ordination of Safety activities for assigned projects covering diverse therapeutic areas Across multiple developmental stages. If you are an experienced Safety professional, please read below?




Responsibilities



  • Coordination and tracking of serious adverse event reporting, study report narratives, reconciliation of documentation, call center function and requests for follow-up information for multiple projects/studies;

  • Coordinate Regulatory Agency case report submission and case report distribution (internal and external) as appropriate

  • Generate periodic and annual safety reports

  • Effectively manage distribution of expedited, periodic, and annual reports to Regulatory Agencies, Ethic?s Committees, and sites in accurate and timely fashion

  • Report adverse events to regulatory authorities as required

  • Provide safety review of clinical study documentation, including protocols, study reports, and marketing application components

  • Finalize all Clinical Safety documents, including safety plans, case reports, Investigator Safety Letters, and narratives

  • Lead Clinical Safety activities for multiple trials and Sponsors

  • Project-specific oversight of Clinical Safety Coordinators and Project Assistants;

  • Provide safety advice and guidance to Clinical Operations including review of protocols, study reports, and marketing application components

  • Provide/propose development specifications for new projects


Requirements



  • Master?s degree and 3 years of clinical safety experience, or Bachelor?s degree and 5 years of clinical safety experience

  • Demonstrate comprehensive knowledge of global safety regulatory requirements

  • Demonstrable experience of write departmental SOPs

  • Be comfortable in a client facing role

  • Ability to train and develop junior team members


If you are interested, get in touch with me ASAP?




Dan Hockaday



Pharmacovigilance & Drug Safety Recruitment Consultant



Email: Dhockaday (at) barringtonjames.com



Phone: 00441293776644



Recent jobs at Barrington James


Viewed: 104 times
« Go back to category
Is this job ad fake? Report it!   
Recommend to a friend
« Home