Federica Sala

Pharmacovigilance Specialist - Local Safety Officer Back-up @Johnson & Johnson Innovative Medicine

Milan, IT

Ensure the day-to-day PV functions are performed satisfactorily and that full regulatory compliance is maintained at the Janssen Local Operating Company level- Act as Local Safety Officer (LSO) back up in case of LSO absence- Responsible for the collection, review and reporting of Adverse Events (AEs), AEs combined with Product Quality Complaints (AEs +PQCs) and pregnancy reports- Assist with initial quality review and assessment of individual cases- Maintain a tracking system to track the cases that require reporting to Regulatory Authorities and submission of cases versus timelines- Reconciliation activities with Company partners- Sceptre database use- Accountable for ensuring the Local Operating Company in the Country meets timelines for management of safety information as per J&J policies and standards- Accountable for implementation of compliance standards and facilitate the collection of compliance metrics as required- Accountable for addressing follow up of missing information from the AE reporter- Performing site visits for special interest cases as requested by LSO.