17 Feb

Drug Safety Validation Specialists - - Foresight Group International

Position
Drug Safety Validation Specialists
Company
Foresight Group International
Location
Opening
17 Feb, 2017 30+ days ago

Foresight Group International as the company that open the jobs vacancy, have some qualification and spesification especially for the Drug Safety Validation Specialists jobs vacancy. To find out more information and about qualification and spesification details, walkin interview schedule, the address of the company, the company contact info (email/phone number) of Foresight Group International company, please start to apply for the job vacancy with fill the jobs application with click the 'Apply This Job' button below.

Country
India

Job Type
Full-Time Regular

Job Description
Role Definition

Involve in the complete life cycle of validating Pharmacovigilance / Drug Safety Adverse Event Reporting Systems at Pharmaceutical companies which includes the analysis of Business and Functional requirements, assessing and mitigating Risks, planning for Validation approach and Test Strategy, developing Trace Matrix, developing and executing Validation Scripts, Defect Management and preparing Validation Summary Report.

Job Duties

Key components of the responsibilities are as mentioned below:

  • Provide application validation expertise on Adverse Event Reporting products including Argus Safety, ArisG, Oracle AERS, Clintrace and related modules
  • Be accountable for authoring Validation Plan, Traceability Matrix and Validation Summary Reports
  • Requirements Analysis and Risk Assessment, Profiling and Mitigation
  • Development, Execution, Approval and Monitoring of the Qualification ( IQ, OQ, MQ, PQ scripts and protocols, results and reports) deliverables for GAMP Software categories
  • Follow the cross-phase procedures and plans like Defect Management Plan, Change Control Procedure, Document Management Plan and Training Plan
  • Closely work with clients and vendors to support implementation and resolve product issues

Education & Other Qualifications
  • BE/ME/MCA/MCS/MSc degree from reputed Institute/University

Essentials
  • 2-4 years of professional experience and strong knowledge with real time experience in Computer System Validation / Software Testing / System Implementation in the Life Sciences industry
  • E xcellent communication, consulting and inter-personal skills
  • Ability to multi-task and work well under pressure
  • Commitment to excellence and high quality standards
  • Versatility, flexibility, and a willingness to work within changing priorities
  • International travel readiness, work hours that overlap global client location Time-zones
  • Well versed with various SDLC models and Software Test life cycle and Defect Management Life Cycle
  • Knowledge of Pharmaceutical / Life Sciences/ Drug Safety domain

N i c e to Have Skills
  • E xperience with Drug Safety Products from Aris Global/Oracle – ArisG/Argus or associated modules like AgExchange/ESM or Safety Mart/Insight
  • Knowledge of regulatory guidelines from the Food and Drug Administration ( FDA) and EMEA
  • H ands-on experience on testing tools like HP Quality Center
  • U nd e rstanding of RDBMS concepts and working knowledge of writing SQL queries


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