Job Description
Key responsibilities of the PV Scientist include delivery of the medical evaluation of single cases and aggregated safety data, signal detection and evaluation activities, delivery of periodic safety reports, contribution to risk management plans and regulatory documents, contribution to definition, implementation and evaluation of risk mitigation actions.
In more details, key responsibilities of the PV Scientist include
Provide timely and accurate medical evaluation of individual and aggregated safety data from pre- and post-authorization sources
Contribute to signal detection from the internal safety database and FDA´s AERS database, and literature reports
Contribute to writing of periodic safety reports (e.g., DSUR, PBRER, pSUSAR report)
Contribute to response documents for Health Authority and EC/IRB requests
Facilitate adequate medical input in case of safety crisis/medical alert situations.