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PV Process Configuration Manager
Temporary position for 12 months in pharmacovigilance at a pharmaceutical company
Het bedrijf / The company
The organisation is an international pharmaceutical organisation that is operational in at least 40 countries across Europe, the Middle East and Africa. The operate on a global level and most of the teams have a global focus. They have everything in house like research, development, manufacturing, warehousing, but also sales and marketing. It is their hope to change tomorrow and to improve the lives of individuals like men, women and children, by providing innovative medicines in areas of health where there is urgent need for better treatments. The organisation is clearly focused on bringing high quality medicines to the market to reach their goals. Wouldn`t it be lovely to join them in their journey? At this moment they are open to meet an enthusiastic candidate for a temporary position as PV Process Configuration Manager at their office in Leiden.
De functie / The role
As a PV Process Configuration Manager you will be responsible for aspects of excellence in Regional PV Process Distribution & Submissions. You will work together with a small team in the Netherlands and report to the Lead Regional. It is an international role where you work extensively with PV Information Management within the region to ensure the quality of outputs as well as system configuration to strengthen the correct functioning of PV Systems, supporting the ongoing assurance of the safety profile. You will also act as a liaison between the teams to translate business requirements into system configuration. You will be working on the compilation and technical implementation of all regulatory requirements and guidelines from the region. You maintain up-to-date oversight and knowledge of all regulatory reporting requirements to Competent Authorities in the region (EMEA: over 100 countries; JP/Asia: appr. 10-20 countries; America: appr. 10 countries). Furthermore, you liaises with Global PV Process and line management to explore and identify the possible impact of any new or revised regulations.
Het profiel / Your profile
• minimum BA/BS, preferably with an advanced professional degree
• minimum of 5 years relevant experience in the pharmacovigilance or combined PV/RA/QA, and/or clinical
• in-depth knowledge and understanding of PV Process regulatory reporting requirements and guidelines in
• in-depth understanding of PV, data management and adverse event reporting
• experience in managing multiple projects in a heavily matrixed and/or cross-functional environment
• a quality mindset and attention to detail to execute QC measures ensuring case submission and compliance are maintained at highest standards at all times
• strong interpersonal skills; able to negotiate and build consensus and able to develop effective relationships through collaboration
• demonstrated ability to think strategically and tactically and generate solutions to complex problems. Able to generate insights and leverage learnings at the individual, team and functional level
• able to lead meetings, present orally and interact with internal stakeholders
• strong working knowledge of and experience with the management of complex global IT systems
Het aanbod / The offer
• an amazing opportunity to use your skills and experience by helping out this client
• a quality orientated organisation in the pharmaceutical industry
• working in an international environment
• a temporary contract or an independent contract from Derks & Derks Secondment & Interim
• a 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/20-076-FMF, to Sandra van Putten: email@example.com. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.