Executive

Opportunity for the candidates experienced into Individual Case Safety Report (ICSR) activities.

This role is to manage the vendor responsible for outsourced Individual Case Safety Report (ICSR) activities. This includes ensuring compliance with contractual obligations, monitoring performance metrics, addressing operational challenges, and maintaining alignment with regulatory requirements.

The role serves as the primary liaison between the organization and the vendor, fostering effective communication, ensuring quality deliverables, and driving continuous improvement in the outsourced processes to meet organizational goals and regulatory standards.

Role & responsibilities

• Monitoring the vendor for all the Individual cases safety reporting (ICSR) outsourced activities.
• Manage the daily workload of ICSR in conjunction with manager, PV operations designee and any other task relevant to PV activities.
• Managing the Vendors on case prioritization on the basis Regulatory and business partner timelines.
• Preforming the daily and monthly reconciliation for the vendor locked cases for billing confirmation including the turnaround time (TAT) calculation.
• Attending the meeting/discussion with the vendor and providing the valuable process enhancement ideas for the process improvement.
• Having oversight on Viatris safety mailboxes to ensure that all the incoming mails are attended to diligently and the relevant actions are completed.
• Liaising with Global PV-Ops teams and affiliates to ensure global procedures are adhered to the process.
• Assist in answering queries and ensuring all cases received from global affiliates via the group mailbox are dealt with timely manner.
• Taking the knowledge enhancement sessions on all the latest regulatory guidelines and presenting the latest update on all procedural documents.
• Conducting the monthly and ad-hoc compliance meetings.
• Training the Vendor team on ad hoc basis and collaborates with the Training team lead to ensure training compliance met within PSRM department.
• As necessary, lead/support audit/inspection readiness activities and represents quality and compliance during audits and inspections.
• Support conduct of inspections and audits and closely collaborate with relevant stakeholders in preparation of internal audits and regulatory inspections.
• Manages and maintains an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis and implementation of quality improvement measures and effectiveness checks.
• Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures.

Preferred candidate profile

Health care professional with experience in Pharmacovigilance and vendor management preferred.