Manager - Pharmacovigilance System Master File
Pharmacovigilance System Manager – Immediate Start Our Client a leading global Pharmaceutical Company has a vacancy for a Pharmacovigilance System Master File Manager within their Safety Team. Within this role you will review the PSMF process and address any technical solutions for a more efficient/cost-effective process, focusing on the main challenges Manage the monthly PSMF updates. The task consists of: - Collecting/requesting data from various stakeholders (including 87 affiliates). - Communicating the requests, clarifying roles and responsibilities, following up on non-responders. - Managing the documentation workflow (including merging data, quality check to ensure it meets the pre-defined standards and liaising with the publication team in Mumbai). Participate in stakeholder meetings (project team, project sub-team meetings) to ensure the PSMF requirements are met and to provide improvement suggestions. Lead some of the sub-team initiatives. When requested, prepare meeting agenda and material and meeting minutes and lead selected meetings. Keep track of agreed actions and follow up on them. Work with source owners to find solutions for a better presentation of the collected data (graphs and tables showing % of compliance as opposed to raw data/line listings). Propose solutions. Train new hires on the above process. Transfer responsibilities. You will work under the supervision of the Office of the QPPV Manager (person responsible for the PSMF). The ideal candidate will have: Excellent process improvement knowledge (proven achievements), preferably in the documentation management and safety systems area. Excellent project management skills and experience demonstrated in the CV, preferably in the documentation management and safety systems area Excellent Drug Safety experience For further information please call Roberta on 0203 465 0044 or email email@example.com
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