Responsibilities
* Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget and are on time with good quality and in compliance with the applicable regulatory requirements.
* Providing support to Director of Projects and senior leadership management as applicable in other activities undertaken on behalf of the client and the company.
* Acting as the primary contact point for project-related matters.
* Workflow management KPI/metric reporting.
* Manage changes to the project scope, project schedule and project costs as applicable.
* Maintaining good client relations and ensuring a consistently high quality of work for each client.
* Understand client PV requirements and ensure service provides addresses all requirements.
* Project set‑up and maintenance activities planning; organising/chairing and attending regular client meetings.
* Having an overview of all tasks to be delivered to the client including deadlines and interim milestones.
* Assurance of training of all team members from relevant quality documents including project‑specific documentation.
* Close cooperation with other Primevigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines.
* Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope.
* Preparation of client‑specific core documents (e.g. Joint operational guidelines, Safety management plan, Monthly reports etc) as applicable.
* Preparation of invoices, project financial analysis.
* Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance.
* Managing Quality Management System activities for the client; development of standard operating procedures and operational guidelines maintaining compliance with the PV system and providing PV training as required.
Qualifications
* Proven track record of demonstrated Pharmacovigilance activities including processing and quality review of IERS, writing or contributing to aggregate reports, literature screening, reconciliation and preparation of SOPs.
* PV Project Management experience from ideally a service provider / CRO.
* Health Care Professional or Life Science Graduate.
* Be comfortable with communicating at senior levels within pharmaceutical organizations.
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