20 Mar

Drug Safety Configuration Lead - - Foresight Group International

Drug Safety Configuration Lead
Foresight Group International
20 Mar, 2017 30+ days ago

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Job Type
Full-Time Regular

Job Description

Role Definition

Involve in configuration of Pharmacovigilance / Drug Safety Adverse Event Reporting Systems at Pharmaceutical companies which includes understanding Business and Functional requirements, prepare design strategy, develop and implement optimized solutions using prototyping and POC techniques where required.

Job Duties

Key components of the responsibilities are as mentioned below:

Provide application configuration expertise on Adverse Event Reporting products including Argus Safety, ArisG and related modules

Requirements Analysis

Development and accountability of document deliverables ( Requirement Documents CBD/CS UDDs SCR Verification IQs etc.)

Design, build and implement configuration for clients

Conduct POCs to understand the effectiveness of the solution; incorporate feedback into the solution

Closely work with clients to support implementation and resolve issues

Implement Quality measures to drive operational efficiencies and articulate the value to the customer

Education & Other Qualifications

BE/ME/MCA/MCS/MSc degree from reputed Institute/University


6-9 years of professional experience and strong knowledge with real time experience in Drug Safety Products from Oracle/Aris Global – Argus/ArisG

Implementation/Upgrade/Maintenance of Drug Safety Application

Working knowledge of writing SQL queries and/or PL/SQL code

E xperience in handling a team

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

N i c e to Have Skills

Working experience on associated modules like Argus J, AgExchange/ESM

E xperience in Customizing E2B profiles

E xperience in configuring Aggregate and Periodic reports

Knowledge of regulatory guidelines from the Food and Drug Administration ( FDA), EMA and PMDA

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