Role Definition :
Involve in the 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 ArgusSafety, ArisG and related modules
- Requirements gathering and analysis
- Authoring and accountability of document deliverables (Requirement Documents, CBD, OQ, PQ)
- 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
- Provide application validation expertise on Adverse Event Reporting products including Argus Safety, ArisG, Oracle AERS, Clintrace and related modules
- Requirements Analysis and Risk Assessment, Profiling and Mitigation
- Development, Execution, Approval and Monitoring of the Qualification (OQ, MQ, PQ scripts and protocols, results and reports) deliverables for GAMP Software categories
- Closely work with clients and vendors to support implementation and resolve product issues
Essentials :
- 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
- Excellent communication and interpersonal skills
- 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
Nice to Have Skills :
- Working experience on associated modules like Argus J, AgExchange/ESM
- Experience in Customizing E2B profiles
- Experience in configuring Aggregate and Periodic reports
- Knowledge of regulatory guidelines from the Food and Drug Administration (FDA), EMA and PMDA
- Strong knowledge with real-time experience in Computer System Validation / Software Testing / System Implementation in the Life Sciences industry
- Excellent communication and interpersonal skills
- Experience on latest technologies like Salesforce, Snowflake, Python, automation testing
- We know that meaningful results require not only the right approach but also the right people.
- Regardless of your role, we invite you to reimagine healthcare with us.
- You will have the opportunity to play an important part in helping our clients drive healthcare forward and
Whatever your career goals, we are here to ensure you get there!
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Tuesday, June 23, 2020
Argus Developer - Applications Implementation/Support/Configuration - SQL/PL-SQL (2-6 yrs) (Kyros Inc)
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