Skip to main content

This job has expired

Clinical Safety Manager

Employer
Barrington James
Location
Scotland (GB)
Salary
Comprehensive Package
Start date
30 Jul 2021
Closing date
29 Aug 2021

View more

Job Details

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

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert