Reference Number: JO-2101-461632
PV Risk Management Scientist
Job Type: Permanent
PV Scientist/Safety Evaluation and Risk Management
Location: North London/Hertfordshire
Salary: Up to 45,000 + benefits
An exciting new opportunity has arisen for a PV Scientist to join a growing generics company. You will be joining a truly global business that has 80 sites around the world with over 10,000 employees.
As a PV Scientist within this organisation, you will be responsible for the scientific evaluation of safety information and the continuous monitoring of the benefit-risk profile of all the company’s pre and post marketed products. You will be responsible for ensuring compliance with global legislation and guidelines that govern the development, registration and commercialisation of their drugs.
– Authoring of aggregate reports (DRURs, PSURs, RMPs)
– Perform Signal detection and evaluation
– Review and provide input into safety sections of study related documents
– Participate in cross-functional safety review teams for products in clinical development
– Support audits, inspections and CAPA management
– Support the EEA QPPV
– Minimum of 5 years drug safety experience within UK Pharma, CRO or Biotech
– Strong understanding of drug development process and drug safety regulatory requirements (EU, US regulations as well as ICH and GCP Guidelines)
– Excellent project management skills
– Experience of working within global PV teams
– Strong verbal & written communication skills
This is a fantastic opportunity for someone who is looking to develop further experience within a scientific PV role. You will have the ability to work autonomously but also willing to work collaboratively with cross-functional teams. Please note that due to current Covid19 restrictions, this role is currently remote but will require an office presence once it is safe to return.
If this role is of interest, please send your CV to George.Danchie@cpl.com or call 0118 959 4990 for more information