JR PHARMACOVIGILANCE SPECIALIST – JANSSEN – SÃO PAULO
Responsibility for timely submission of Individual Case Safety Reports - ICSRs (adverse events, adverse events associated with Product Quality Complaints – PQCs, and special situation) to Global processing center and local Health Authorities.
The PV Specialist works in partnership with the LSO to ensure that LOC Pharmacovigilance activities are managed in compliance with local regulations and company policies/procedures and in accordance with any Pharmacovigilance agreements with business partners.
▪ Process ICSRs (inbound and outbound):
- Collect, review and report ICSRs obtained from all applicable sources, within the appropriate timelines.
▪ Follow-up of ICSRs.
▪ Monitor and review the PV mail box, ensuring responses are provided and actionable items are addressed on a timely manner.
▪ Review and manage the investigation results from the Quality Assurance Group for adverse event reports associated with a product quality complaint, as appropriate.
▪ Support the LSO in the reconciliation of ICSRs between areas of interface with PV.
▪ Support LSO in the preparation of response to any safety related query or relevant communication from the Local Competent Authority.
▪ Support LSO in the compliance review of ICSRs reporting process.
▪ Perform quality activities such as targeted follow-up questionnaire reconciliation and monthly compliance reports.
▪ Search and review regional scientific literature articles for safety information, and process any identified ICSRs as applicable.
Brazil-São Paulo-São Paulo-
Janssen Cilag Farmaceutica Ltda. (7585)