Job Description

The Role

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).

This position has some procedural accountabilities and may undertake additional activities as requested by their manager, including project work at the regional and global level and may mentor PV staff.

This role can be completed from any country in EMEA that we have an office location.

Key Responsibilities

• Support the implementation, maintenance, and continuous improvement of the IPV Quality Management System (QMS), ensuring alignment with global standards and regulatory expectations.
• Provides 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.
• Supports audits and inspections (e.g., Country, Local/Regional External parties, systems) including readiness activities and execution.
• Responsible for the Country PV Audit CAPA management facilitation ensuring development of CAPAs in response to findings/observations.
• 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.
• Responsible for interfacing and interacting with Country PV and GCS&PV staff for ensuring regionally applicable global standards/systems establishment and maintenance, and addressing relevant issues.
• 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.
• Provides 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.
• 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.
• 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.
• Provide guidance and support on compliance activities (e.g., issue management activities, self-inspection activities).
• 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).
• Support PV intelligence monitoring, interpretation, and implementation of new/updated PV legislations as required.
• 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).
• Ensure PSMF or CCPD process/updates are accurate liaising with the GQPPV Office or other stakeholders as applicable.
• Support compliance metrics for additional risk minimization measures and establish key performance indicators.
• Support IPV training execution strategy including IPV training curricula maintenance.
• Support country and regional PV teams by providing subject matter expertise related to the Global Safety Database, helping ensure consistent understanding and application.
• 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.
• May serve as the back-up to PV Lead or any IPV role within assigned countries for certain activities in periods of absence.
• May participate and represent IPV on special projects or rotational assignments within or outside of IPV as part of their professional development.
• Act as a mentor PV staff on pharmacovigilance topics as required.
• 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.