Berufsbezeichnung: Argus Safety System Architect

Arbeitsbeschreibung:
Responsibilities: • Single technical point of contact for Argus Safety system all its interfacing systems. • Perform Solution Architect tasks for Argus Safety during operational change and release management. • Ensure the application meeting Regulatory Compliant state and client information security requirements. • Planning and Control of techno-functional analysts aligned to the group. • Technical expertise for industry specific standards such as MedDRA, WHO Drug, E2B specifications etc. • Sound expertise in submissions with major regulatory authorities such as FDA, EMA, Health Canada etc. • Interface with other project stakeholders both internal and external to ensure client’s practices are aligned with regulatory expectations and industry best practices • Ensure resources involved in the engagement receive required technical training. • Ensure applications remain compliant during operations on • GxP, CSV, ISEC. • Perform Technical Reviews (i.e. Change & Release management, IT In-control assessment) to ensure applications remain validated. • Control compliance of Technical Standards for CTS associates within his/her domain or application support team • Coach/mentor technical resources for technical and domain competencies. • Recruit and supervise Technical Resources. • Participation in Capacity Planning, Audit planning and participation. • Liaise with customer groups and other dedicated IT functions to optimize user support. Ensure close collaboration with appropriate system owners and key stakeholders in business. • Ensure compliance of a GxP application’s operation and maintenance during its operational life. • Ensure stable and efficient operation of the IT applications. Your profile: • Minimum requirement is a Bachelor’s Degree in Computer Science, Sciences or a related education (e.g. life science, medicine, commercial). • >=8 Professional experience working in regulated environments in a Pharmaceutical/Life Sciences Organization. Of which >=4 years of experience is as Solution Architect/Technical SME of Argus Safety. • Extensive experience in development/maintenance of Argus Safety customizations and its interfaces. • Good understanding / knowledge of Computer Systems Validation (CSV) and change management in a GxP environment. • Strong technical and functional knowledge of Pharmacovigilance IT Systems • Strong technical and functional knowledge of Argus Safety (an Adverse Event Reporting System) suite of products • Strong technical and functional knowledge of MedDRA, WHO Drug dictionaries • Sound expertise in submissions with major regulatory authorities such as FDA, EMA, Health Canada etc. • Extensive hands on experience in Oracle PL/SQL

Angestelltenname: Cognizant

Arbeitgeber-Adresse: Cognizant Hohlstrasse 560 8048 Zürich

Form von Kontakt: eric valentin

Arbeitgeber Telefonnummer: +41 44 286 60 58

Stellenkurzbeschreibung: Softwareentwickler

Land: Schweiz

Region: Basel-Stadt

Vertragslaufzeit: Unbefristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Uni/HS

Erfahrung: 5 Jahre und mehr

Quelle des Stellenangebots:
SECO,Öffentliche Arbeitsverwaltungen, Schweiz (Confoederatio Helvetica)

Fahrerlaubnis: Nein

Wie Sie sich bewerben: Weitere Angaben (siehe Beschreibung)

Gehalt Währung: CHF

Gehaltsperiode: Gehalt Periode nicht spezifiziert

Gehalt Besteuerung: brutto