Junto HLS has been engaged by Leadership at a Top 20 pharma to recruit an Associate Director, Global PV Reporting & Vendor Management.
- Provide leadership and oversight to vendors performing ICSR submissions; ensuring adverse event information is processed according to company timelines and quality standards.
- Lead PV relationship with the PV BPO Vendor and/or vendors performing PV Processes and Global Expedited Reporting and Submissions to ensure compliance with SLAs.
- Manage and oversee company requirements for global ICSR reporting and distribution to Regulatory Authorities, LOCs, Alliance partners, CROs and Ethics Committees; Ensure accuracy of safety system configuration against the reporting requirements.
- Responsible for communication and collaboration with Global PV functions and regulatory intelligence to assist with seamless systems for compliant reporting to Health Authorities.
- Oversee regulatory submissions for ICSRs from the Global Safety database, on-time delivery of adverse event reports to Global Health Authorities, alliance partners, LOCs, ECs, vendors and investigators and development of and implementation of a methodology for regular quality assessments.
- Oversee and manage communication with alliance partners, vendors, CROs and internal partners regarding the evaluation and processing of ICSRs.
- Represent Global Pharmacovigilance Operations in internal audits and Health Authority inspections related to global expedited reporting and submissions.
- Approve Alliance Partner safety data exchange agreements for appropriate ICSR safety reporting processes and exchanges ensuring compliance with global expedited reporting requirements.
- Responsible for update of reporting requirements and ensuring the Global Safety Database configuration is updated with new or revised Alliance Partner safety data exchange agreements requirements.
- Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs, processes, reporting reference materials and metrics.
- Monitor performance, accuracy, compliance, and training on Global Expedited Reporting and Submissions at a global level.
- Support LOCs in PV tasks responding to queries and requests regarding case handling and expedited reporting.
- Partner with QA to establish and manage vendor quality agreement procedures related to PV Processes and Global Expedited Reporting and Submissions.
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.