This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
To write/ review QA documents such as SDEA’s, Working Instructions, SOPs, Working Procedures, templates, project metafiles etc. for PharmaLex Pharmacovigilance projects
To organize and perform training of the above-mentioned documents
Identification (Classification of references) of safety- relevant publications in the scientific literature. Provision of scientific input in the course of literature surveillance service
Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers
Medical assessment of literature reports into the safety database
Act as main contact for client/project management
The employee agrees to take over primary listed tasks and responsibilities in other service lines and additional reasonable tasks that align with their abilities, qualification and training, if required
Responsible for quality management, workload management, compliance management and document management for the assigned PV projects
Acts as line manager of assigned staff
Manages project coordination and resource allocation within the projects
Train and mentor PV department staff, as needed
Ensures monthly invoices are generated and shared for all PV clients on regular/monthly basis
Responsible for recruitment of new staff in PV Department
Is involved in objective setting and annual appraisals of staff
Ensures training compliance by PV staff at all times
Represents PV department during for-cause/maintenance client audits or regulatory authority inspections
Requirements:
University degree in Life Science
Minimum 10 years of experience and profound knowledge in the field of pharmacovigilance
Good communication skills (written and verbally)
capability to point out issues and provide potential options for solution in the area of expertise