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Pharmacovigilance Process Compliance Manager
Temporary position to check if the compliance process has been followed for PV
Het bedrijf / The company
Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has a tight line all around the world. The organisation is looking for support for the Pharmacovigilance department. They would like to come in contact with an experienced and enthusiastic Pharmacovigilance Process Compliance manager.
De functie / The role
As Pharmacovigilance Process Compliance Manager, you will be responsible for the coordination of the root cause analysis for later cases, trends and issues. You will liaise with QMS for compliance monitoring tools (e.g PV monitor) to ensure business needs are met. You will also support in discussions with e.g. license partners for compliance related matters in collaboration with QMS. Furthermore, you will maintain oversight of global Case Processing data quality review activities such as daily retrospective QC, ad hoc targeted QC such as listedness, coding, off line medical confirmation reviews. You will run the coordination of root cause analysis for case quality issues and trends related to global PV process in collaboration with GME, and (QC) vendor. You will also support in executions of targeted QC as and when need and support in the identification and implementation of other case processing performance metrics such as follow up effectiveness and case deletions. In this position you will work extensively with PV Process Regional Management Leads and Staff, Global Medical Expert, Quality Management System (QMS) staff as well as selected vendor personnel, to identify opportunities for Quality and compliance improvement and ensures that PV process deliverables directly support the ongoing assurance of the safety profile of products. You will report to the manager of the department.
Het profiel / Your profile
o minimum M.Sc. degree in Life Sciences
o minimum of 3 years relevant experience in Pharmacovigilance
o demonstrated experience in a compliance and/or quality assurance/control function
o demonstrated interpersonal skills and multi-cultural /intercultural awareness
o demonstrated ability to proactively resolve complex problems
o experience with safety databases
o good oral and written communication and presentation skills in English
Het aanbod / The offer
o a diverse job in Pharmacovigilance at a pharmaceutical company
o an interesting job because of the international contacts
o a temporary contract for 12 months, with the possibility to extent
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/18-149-FMF, to Sandra van Putten: firstname.lastname@example.org. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.