Clinical Safety Manager

Location
Scotland (GB)
Salary
Comprehensive Package
Posted
30 Jul 2021
Closes
29 Aug 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

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