Job Description

Role Overview

The Regional PV Officer for EMEA region (covering IPV Europe and EEMEA regions) is responsible for supporting and overseeing pharmacovigilance activities that assist the PV Regional Head, Clusters Leads, PV Leads, and their teams within their assigned region. In addition to country-level support, the Regional PV Officer is a subject matter expert (SME) for identified activities regionally and/or globally. This role interacts and liaises with global GCS&PV colleagues, as well as with colleagues across departments such as Regulatory Affairs International (RAI), other functional areas, and business process owners for example in Global Clinical Trial Operations (GCTO) and Global Medical and Scientific Affairs (GMSA).

Key Responsibilities

• Support Implementation and Maintenance: Ensure the alignment of the IPV Quality Management System (QMS) with global standards and regulatory expectations.
• Expert Guidance and Operational Support: Provide expert guidance and operational support to country PV teams on all and/or targeted pharmacovigilance matters, ensuring alignment with global processes and procedures, and supporting compliance across local regulatory environments.
• Audit and Inspection Support: Support audits and inspections, including readiness activities and execution. Responsible for Country PV Audit CAPA management facilitation ensuring development of CAPAs in response to findings/observations.
• Knowledge Sharing and Compliance: Support knowledge-sharing related to the addition or update of reportability rules and other relevant reference data in the Global Safety Database, ensuring alignment with regulatory expectations and internal standards.
• Interface and Interaction: Interface and interact with Country PV and GCS&PV staff for ensuring regionally applicable global standards/systems establishment and maintenance, and addressing relevant issues.
• Pharmacovigilance Submissions: Responsible for the execution of regionally required pharmacovigilance submissions, such as Aggregate reports (e.g., EUCTR DSURs) ensuring alignment with global timelines, regulatory requirements, and internal procedures.
• Compliance Monitoring: Provide guidance on complex cross-functional scenarios and independently provide innovative solutions to matters raised from country PV staff related to operational pharmacovigilance activities, and local initiatives. Responsible for performing compliance monitoring activities according to the internal procedures for individual case safety reports and aggregate safety reports and lead or participate in non-compliance investigation and documentation.
• Document Coordination: May coordinate translation of PV documents (as applicable). Support the preparation, review, and maintenance of Local, Regional, and/or Global IPV procedures as required. In some instances, owns procedural documents.
• Documentation Stewardship: Serve as a documentation steward for the IPV organization by ensuring the accuracy, consistency, and timely maintenance of procedural documents, records, and knowledge assets, in alignment with internal standards and regulatory expectations.
• Compliance Activities: Provide guidance and support on compliance activities (e.g., issue management activities, self-inspection activities).
• Contract Management: Responsible for ensuring appropriate contract management activities (e.g., PV language inclusion, due diligence activities, compliance reviews (when needed)) for Regional PV agreements, liaising with appropriate stakeholders (e.g., local PV staff, business partners, vendors, and Alliance Managers).
• PV Intelligence: Support PV intelligence monitoring, interpretation, and implementation of new/updated PV legislations as required.
• Information Coordination: Coordinate and gather Pharmacovigilance information and/or regulatory requirements, as required from local country operations and assist if applicable in summarizing information (e.g., via survey, direct communication).
• PSMF/CCPD Process: Ensure PSMF or CCPD process/updates are accurate liaising with the GQPPV Office or other stakeholders as applicable.
• Compliance Metrics: Support compliance metrics for additional risk minimization measures and establish key performance indicators.
• Training Support: Support IPV training execution strategy including IPV training curricula maintenance.
• Subject Matter Expertise: Support country and regional PV teams by providing subject matter expertise related to the Global Safety Database, helping ensure consistent understanding and application.
• Meeting Participation: Participate in regional/Cluster/global meetings and support planning and facilitation of global/regional/cluster face-to-face or virtual meetings with global PV colleagues.
• Backup Support: May serve as the backup to PV Lead or any IPV role within assigned countries for certain activities in periods of absence.
• Special Projects: May participate and represent IPV on special projects or rotational assignments within or outside of IPV as part of their professional development.
• Mentorship: Act as a mentor for PV staff on pharmacovigilance topics as required.
• Training Compliance: Responsible for completing all required/applicable trainings assigned at the time of hire and after hire by the due dates, before performing the activity. Ensure all activities are conducted in compliance with applicable regulations, internal procedures, and company policies, consistently meeting quality standards.