21 Mar

Drug Safety Validation Specialists - - Foresight Group International

Drug Safety Validation Specialists
Foresight Group International
21 Mar, 2017 30+ days ago

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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


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

Other Drug Safety Validation Specialists Jobs Vacancy


Drug Safety Senior Validation Specialists. Job Openings in Foresight Group International for Drug Safety Senior Validation Specialists, this job opened at 27 Jun, 2017. Knowledge of Pharmaceutical / Life Sciences/ Drug Safety domain. E xperience with Drug Safety Products from Aris Global/Oracle – ArisG/Argus or associated... ... (Read more about Drug Safety Senior Validation Specialists - Noida - Foresight Group International)