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Wipro Openings in Switzerland - openings Subject Matter Expert - Validation, Subject Matter Expert – Regulatory & Safety (Clinical Development)

Job Title: Subject Matter Expert - Validation
Job Location: Basel/Switzerland

Job Title:
Subject Matter Expert - Validation

Job location: Basel/Switzerland

Job Type (Permanent/Contracting): Permanent position

    We are currently looking for professionals fulfilling the following criteria:
  • Computer System Validation & Part 11 Compliance (V&V)
  • Knowledge on software implementations and validations (Installation, Operational and Performance Qualifications)
  • Knowledge on GMP, GaMP , USFDA etc., practices
  • Expertise in Regulatory Standards of ICH, USFDA, EMEA, ISPE, PIC/S, TGA
  • Worked in eCTD (Docubridge), SPL-PLR, SAP, Orcale Clinical applications
  • Expertise in Process Validation and Qualification


Please send your resume to heike.krueger@wipro.com , mentioning "SME - Validation - Facebook" in the subject line in case your profile matches the criteria mentioned.


Job Title: Subject Matter Expert – Regulatory & Safety (Clinical Development)
Job Location: Basel/Switzerland

Job Title:
Subject Matter Expert – Regulatory & Safety (Clinical Development)

Job location: Basel/Switzerland

Job Type (Permanent/Contracting): Permanent position

    We are currently looking for professionals fulfilling the following criteria:
  • Strong industry awareness (Life Science) and proven Client Relationship Management and Business Development Skills and excellent interpersonal and communication skills
  • Knowledge of principles of Clinical development and Drug safety / PV, GxP guidelines including ICH-GCP guidelines, comprehensive understanding of regulatory compliance and FDA/EMEA regulation, guidelines, directives and any relevant regulatory requirements
  • Experience in adverse event processing; safety data analysis and reconciliation; database management, aggregate safety reports ,compliance metrics development and signal detection activities thus complying with the standards and expectations of global regulators
  • Exposure to Global Regulatory Standards of ICH, USFDA, EMEA, ISPE, PIC/S, TGA
  • Worked in Clinical and safety applications
  • Expertise in Process Validation and Qualification
  • Knowledge in Computer System Validation & Part 11 Compliance (V&V)
  • Worked in Pharma / CRO industry managing clinical / safety areas
  • Strong consulting experience
  • Exposed to working with outsourcing organizations
  • Managed EDC ,TMS, SAS from CDM perspective and case processing from drug safety
  • Experienced in Clinical integrations, validations, LSH, CDA
  • Proven expertise with CDISC standards and conversions


Please send your resume to heike.krueger@wipro.com , mentioning "SME – Regulatory & Saftety - Facebook" in the subject line in case your profile matches the criteria mentioned.













Please read the advertisement document carefully and make sure you are eligibile as per the eligibility criteria mentioned in the document.


Please visit the recruiter's official website to confirm the recruitment information, read the official job notification carefully and make sure that you are eligible for the respective post and then apply. It is applicants responsibility to confirm the validity of Job opening.



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