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The Local Pharmacovigilance Specialist is responsible for the execution of tasks and all aspects of technical delivery in the field of Local Pharmacovigilance.
Job Responsibility:
Data entry and quality control of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature
reporting of ICSRs to the competent authorities
Support in the generation, processing, documenting, and tracking of follow-up requests
Screening and documentation of scientific literature regarding safety relevant publications
Assist in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports
Interact with customers as needed (e.g. meetings, client visits, day to day case processing, etc.)
PSMF maintenance
Contribute to/review QA documents such as Working Instructions, SOPs, Working Procedures, templates, project metafiles, etc. for pharmacovigilance projects
Prepare for and participate in internal and external audits/inspections
Training new colleagues in relevant tasks
The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required
Requirements:
Professional education or University degree in Life Science preferred but not essential
Basic understanding/knowledge in the field of pharmacovigilance and medical information
Ability to prioritize and manage own time and tasks
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
Good communication skills (written and verbally)
capability to point out issues and provide potential options for solution in the area of expertise