Clinical Safety Manager
- Employer
- Barrington James
- Location
- Scotland (GB)
- Salary
- Comprehensive Package
- Start date
- 30 Jul 2021
- Closing date
- 29 Aug 2021
View more
- Discipline
- Clinical Research, Drug Safety, Pharmacovigilance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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.
- Website
- https://barringtonjames.com/
- 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