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    Senior Specialist - Platform Technologies (Argus)

    Pharmalex
    2+ years
    Not Disclosed
    Mumbai
    10 Oct. 29, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Location: Noida/Mumbai, India (Hybrid)

    Your Job:
    As a Senior Specialist in Platform Technologies focusing on Oracle Argus, you will play a pivotal role in providing consulting and support for PharmaLex’s Argus Hosted service. Your responsibilities will include:

    • Consulting & Support: Deliver direct consulting and support related to Pharmacovigilance and Safety Database systems, particularly within the Argus Hosted service.
    • Training & Implementation: Provide training and support for both client-facing and internal projects regarding Argus functionalities and services.
    • Technical Solutions Development: Assist in the design, development, implementation, and enhancement of technical solutions for the Pharmacovigilance area, specifically the Argus rapidLIVE package, which includes:
      • System setup and configuration
      • Creation and guidance for validation documentation
      • Development and conduct of training materials
      • Ongoing support during implementation and post go-live phases
    • Business Needs Analysis: Analyze complex business requirements presented by clients and internal teams, recommending and implementing effective solutions.
    • Project Management: Provide project management and oversight for both client implementations and internal PharmaLex projects.
    • Documentation Development: Assist in creating and reviewing relevant documents, procedures, and working instructions (SOPs, WIs, FAQs) to support Pharmacovigilance activities while ensuring adherence to defined policies.
    • Version Updates Management: Deploy version updates, hot-fixes, and patches following controlled change request procedures.
    • Migration Participation: Participate in the design and execution of migrations for Oracle Argus.
    • Business Development Support: Contribute your expertise as a Subject Matter Expert (SME) during the Business Development process.
    • Other Responsibilities: Undertake any additional responsibilities as agreed upon with your Supervisor, including strategic initiatives for Platform Technologies.

    Your Profile:

    • Experience: 3-5 years in the Life Sciences industry with a focus on pharmacovigilance.
    • Education: Bachelor of Science in computer or natural sciences, or a comparable qualification.
    • Technical Skills: Experience with Oracle Argus technical and functional support, along with proficiency in PL/SQL programming and general knowledge of database structures/models.
    • Validation Knowledge: In-depth knowledge of computerized software validation (CSV), including GAMP 5 and 21 CFR Part 11.
    • Regulatory Compliance: Experience working in GxP-governed environments and those controlled by Information Security Management Systems.
    • Project Management: Preferred experience in project management.
    • Communication Skills: Strong communication abilities with fluency in English.
    • Organizational Skills: Highly organized with a keen attention to detail and analytical skills, capable of multitasking and handling competing priorities.
    • Team Collaboration: Ability to work collaboratively within a team while also thriving in independent tasks.
    • Proactive Approach: A proactive mindset focused on continuous improvement and growth for yourself, the Platform Technologies Team, and PharmaLex as a whole.

    If you are excited about this challenging opportunity to join our PharmaLex team, we look forward to receiving your application, including your earliest possible starting date, any visa requirements, and salary expectations.

    For further information, please don’t hesitate to contact us.

     

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