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Sr.Executive/ Asst.Manager-CDMA (Pharmacovigilance)

5.00 to 8.00 Years   Hyderabad   16 Mar, 2022
Hetero
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

    Technical Role: 1. Having Experience in Registration, Gateways Setup, Reporting destination configurations with Health authorities (USFDA, EMA, MHRA) and communications with health authorities support team.2. Having hands on experience with requirements gathering, analysis, functional design and technical development, experience especially in Argus safety Level 1,2,3,4 support.3. Having experience in performing technical development, patch upgrade/ implementation as a part of Argus projects.4. Hands of experience in MedDDRA, WHO-DD patch upgradations.5. Experience in data migrations of from server to cloud and extracting data with SQL/PLSQL.6. Experience on Business Configuration (Product & license configuration, Study ID configurations, Reporting rules configurations).7. Experience in Maintenance of Code list (ARGUS, Flexible date re-categorization).8. Experience on Access Management (Sites, Groups, User configurations).9. Experience in System Management (Reporting rules and work flow configurations).10. Experience in Line Listing generation for Aggregate reports (ICHPSUR, NDA).11. Experience in Generation of Summary tabulations, Medical summaries for SIGNAL and RMPs12. Experience in Generation of customized CDA, CIOMS II as per the user requirement.13. Having experience in creation of Customized Advance conditions for extraction of required data on requests.14. Experience in handling Oracle support portal regarding CRN related to Argus.15. Experience in CSV documentation preparation the projects related to PV.
    • User Requirement Specification
    • Initial Risk Assessment
    • Functional requirement specification
    • Functional requirement Assessment
    • Validation Plan
    • Installation Qualification and documents
    • Operational Qualification and documents
    • Performance Qualification and documents
    • Traceability matrix
    • Validation summary report
    Functional Role:1. Handling of compliance checking of cases in Argus.2. Performing peer review of reports against Argus safety data base, CIOMS, Med Watch and E2b reports.3. Having experience in performing review of cases and E2b validation checks.4. Responsible for providing inputs and drafting of SOPs related to PV. ,

Keyskills :
functional designargus safetyaccess managementrequirements gatheringoracle supportriskcloudsummarizing informationmusic making

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