Safety Scientist

Location
Hertfordshire, St. Albans, England
Salary
£35 - £45 per hour
Posted
01 Aug 2019
Closes
29 Aug 2019
Ref
TJB458937
Contact
Tim Barratt
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
Within this role you will support the safety risk management of assigned products across the lifecycle including early and late phase development safety activities as well as safety activities for marketed products.

Responsibilities:
● Responsible for aggregate case reporting activities and aggregate reporting (e.g., DSUR, PBRER)
● Responsible for signal detection and management activities including, including respective documentation and drug safety reports.
● Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
● Contributing to study management through cross-functional teams and document review across the development continuum (early phase to post marketing studies), including PASS
● Interfacing with business process owners on processes executed by Safety Science
● Coordinates and assists in Health Authority interactions and responding to requests
● Responsible for supporting processes involving safety science
● Responsible for carrying out activities related to quality system management for safety science

Education, Skills and Experience Minimum:
*Bachelor's degree in healthcare related field or equivalent experience
● Work experience in pharma safety, pharmacovigilance or other related pharmaceutical development area of at least 2 years
● Appreciation of GVP and GCP and regulated processes and end to end clinical trial lifecycle
● Understanding on application of data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
● Able to work with remote partners and teams across global sites
● Excellent communication skills, both written and verbal
● Fluent in English Location: Basel

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk