Specialist, Regulatory and PV Network

The Specialist, Regulatory and PV Network is responsible for providing the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies. The Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country. Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates. Provide intelligence on requirements and contribute to the development of the strategy and set up activities. Support identification of issues and corrective actions. Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports and ensure correct training assignment to and training compliance by the LCPs. Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.