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Global PV Process Manager
Temporary position for 6 months in Global Pharmacovigilance processes at a pharmaceutical company
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 tight lines all around the world. The organisation is looking for support for the Global Pharmacovigilance department focussing on the vendor management processes.
De functie / The role
As a Global PV Process Manager you are responsible for accurate support of Global PV Process Global Management functions to enable timely and high quality execution of vendor activities, global medical expert activities, and PV process governance activities. You will contribute to the successful execution of the Global PV Process objectives, supporting the overall GPV mission. In this role you will be responsible for coordinating projects related to in-house or outsourced case processing activities. You maintain expert knowledge of assigned PV Process processes and procedures. Furthermore, you execute ICSR processing related maintenance activities. Act as Subject Matter Expert in audits and inspection in relation case processing procedures will also be a responsibility. You will work extensively with PV Process Regional Management Leads and Staff, as well as selected vendor personnel. Together you will identify opportunities for improvement that directly support the ongoing assurance of the safety profile of the products based on Quality Control findings. In the role you will be joining a global team and you will report directly to the Global PV Process Governance Lead. Your other stakeholder will be the Global Medical Expert or Global Vendor and Outsourcing Lead.
Het profiel / Your profile
• at least a BA/BS in life sciences
• minimum of 2-3 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development
• a technical expert within the organisation, with extensive knowledge within their chosen specialty and developing knowledge of related disciplines
• has the ability to recommend enhancements to internal policies, processes and procedures based on new requirements, legislation, etc.
• provides solutions to a wide variety of problems of greater complexity that require the regular use of creativity and ingenuity, while safeguarding Astellas' compliance
• self-directed within the scope of his/her duties and responsibilities
• contributes to or completes projects independently as directed
• extensive PV knowledge
• experience with safety databases
Het aanbod / The offer
• a diverse job at a pharmaceutical company
• an interesting job because of the international contacts
• a temporary contract for 6 months, with the possibility to extent
Reactie / Reaction
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-052-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.