• Responsible for defining standards for PV process related matter and procedure in linne with global PV process strategy.
• Development and maintenance of global standards and processes for case processing and related activities.
• Responsible to define standards for AE intake requirements.
• Continuously assess processes and identify opportunities to improve efficiency, effectiveness and compliance.
• Able to lead projects to the implementation of process improvements.
• Manage planned and unplanned deviations and ensure accurate periodic review.
• Assist with setting standards, decision making and maintenance of product specific case handling conventions in consultation with PV Process Management
• Management for Argus system changes to ensure accurate and timely assessment of impact to global PV process
• Liaison with PV functional teams (Medical Safety Science) for impact of process changes.
• Perform impact analysis for global regulatory intelligence results
• Maintain standards and procedures for identification and management of Product Quality Compliants associated with safety information coordination with other PV functions and QA units related to triage, case processing, investigation, reconciliation and reporting.
• Assist PV Process as SME during audits and inspections

If you have any questions:
Marije de Graaff
Leiden@unique.nl
+31(0)71-5160450

• You're living in The Netherlands;
• Fluent written and verbal communication in Dutch and English;
• Minimum MSc in life sciences;
• Minimum of 7 years relevant experience in PV or combined PV/RA/QA and/or clinical development;
• Extensive PV knowledge;
• Strong interpersonal skills and multicultural awareness;
• Able to lead complex process improvement projects;
• Able to negotiate and build concensus for plans and priorities and develop effective relationshiops through collaboration;
• Able to make decisions and involves management at the right momentExcellent oral and written communication skills in English, with an ability to interact with all levels of personnel, and global SMEs;
• Demonstrated ability to practively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across global organization;
• Able to interpret, execute and recommend changes to established policies and programs;
• Leadership, decision making and negotiaton skills;
• Independent worker;
• Strong analytical skills;
• Six Sigma or similar process improvement methodlogy knowledge a plus;

• Fulltime job in an international environment;
• Good working conditions;
• Good salary: 6000 - 69000 (based on working experience);

This company it an international pharmaceutical company positioned all over the world, this job is recuired in Leiden.
The company is easily accessible by public transport from Rotterdam, The Hague and Leiden. Also it is possible to come by car they have a large number of parking spaces at the company.