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Senior Manager PV Process Governance
As Senior Manager PV Process Governance, you will be responsible for the following: - Responsible for defining standards for PV process related matter and procedure in line 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 ...
Het bedrijf / The company
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V. we are searching for a Senior Manager PV Process Governance
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people world-wide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
De functie / The role
As Senior Manager PV Process Governance, you will be responsible for the following:
Responsible for defining standards for PV process related matter and procedure in line 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 co-ordination 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.
Het profiel / Your profile
The ideal candidate has at least an M.Sc. in Life Sciences with 7 years of relevant experience in PV or combined PV/RA/QA and/or clinical development. You have extensive PV knowledge (including case processing) and good project management skills as you are required to run process improvement projects. You will be working in a global team and, therefore, we are looking for someone with strong interpersonal skills and multicultural awareness.
Are you the open and pro-active team player we are looking for?
Het aanbod / The offer
Project till at least March 2022.
Reactie / Reaction
Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form and click below at button "".
Tenslotte ..... / Finally ....
Reference:A2000166 Contract:Temporary contract with CLS Services Education:WO/MSc. Employment terms:Project till at least March 2022.Publication date:11-11-2020Contactperson:René Kemps+31 (0)31 (0)88 22 77 555
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.
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