Responsibility for coordinating the Pharmacovigilance (PV) team for Latin America to ensure timely submission of Individual Case Safety Reports - ICSRs (adverse events, adverse events associated with Product Quality Complaints – PQCs, and special situations) to Global processing center and local Health Authorities.
Liaise with the LSO to ensure that the LOC Pharmacovigilance activities are managed in compliance with local regulations and company policies/procedures and in accordance with any Pharmacovigilance agreements with business partners.
Develop the team under his/her responsibility.
Duties & Responsibilites
Conduct performance reviews and develop the team under his/her responsibility.
· Coordinate the PV team for coverage of inbound and outbound processing, follow-up of ICSRs, regional scientific literature search query responses.
· Ensure quality activities are conducted on time, such as targeted follow-up questionnaire reconciliation, annual review and monthly compliance reports.
· Assign tasks and projects to team members based on their performance and development, and considering the team needs.
· Daily monitoring of the workload related to ICSRs processing (inbound, outbound, follow-up, etc) to identify contingency needs (e.g. redistribution of tasks).
· Conduct Inspection Readiness activities.
· Implement Corrective and Preventive Actions.
· Write and review local standard operating procedures related to PV area.
· Review metrics and key performance indicators to improve compliance, identify training needs and optimize local processes.
· Maintain the training program for PV team.
· Ensure effective and constant communication between team members.
Brazil-São Paulo-São Paulo-
Janssen Cilag Farmaceutica Ltda. (7585)