PV Specialist

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Timely processing of pharmacovigilance (PV) and other vigilance cases in line with regulations, procedures, and internal quality systems.
Monitoring potential PV data sources and other vigilance
Execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation
Ensures the reception and sorting of emails from the generic mailbox of the PV Unit team
Identifies PV cases or other vigilance for processing
Performs the search for duplicates, enters PV cases and other vigilance in the local database
Performs quality control of PV cases and other vigilance in the local database
Transmits PV cases and other vigilance to the global database or to partners according to the internal requirements and respective Agreements in force
Ensures the anonymization of source documents and their recording and archiving if applicable
Performs documentation attempts of cases with reporters if applicable
Responds to requests for clarification and/or translation requested by the global PV department
Participates in the implementation of processes for the management and monitoring of PV data sources
Performs periodic reconciliations of Pharmacovigilance data from PV case sources and other vigilance
Checks the assessment of the severity criterion and the proper management of information in the global case database
Ensure compliance with submission deadlines to the competent authorities
Contributes to the identification and management of deviations and contributes to the implementation and monitoring of CAPA
Participates in the drafting and implementation of quality documents and in the department's compliance monitoring activities and develops indicators on case management (compliance and performance indicators)
Participates and helps with local and/or global audits and inspections including support in development and implementation of CAPAs in response to deviations.
Participates in the training of company employees, distributors, subcontractors, business partners, including training documentation.
Supervise and coordinates activities delegated to service providers according to contractual terms

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