ProductLife Group is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services. All ProductLife Group’s services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes.
Poste et missions:
As a result of a new project we are now seeking a drug safety officer.
- Contribute to pharmacovigilance activities performed on the Platform. Pharmacovigilance activities include pre-marketing activities, post marketing activities and interaction with health authorities on behalf of ProductLife’ s customers
- To contribute to the production of client administrative documents to be included in regulatory submissions
- Undertakes data entry and document management for Pharmacovigilance aspects of allocated studies
- Understand and interpret clinical and scientific reports to allow the accurate capture of safety data
- Responsible for the triage, case processing and document management of safety documentation. Safety information to manage includes Adverse Events (AEs), Serious Adverse Event (SAE) reports from clinical trials, spontaneous reports, health authority reports and literature reports
- To manage the safety mailbox and ensure that case timelines are accurately assessed and recorded for continued compliance
- Liaise with health care professionals (HCP) & Study investigators to collect follow up information
- Assist the Drug Safety Specialists, Drug Safety Officers and other project staff with PVG project related tasks as required.
- Bachelor’s or higher graduate degree in a science related field, or equivalent experience
- 1 year of experience in a similar position/pharmaceutical industry
- Good understanding of safety database software and MS Office
- Effective oral and written communication skills in English, any other language would be an asset
- Process orientated with good attention to detail
- Good computer skills and the ability to learn appropriate software.