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Senior Specialist - Platform Technologies (Argus)

2+ years
Not Disclosed
10 Oct. 24, 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

Grow with Us!
Are you seeking a dynamic company that offers daily challenges and opportunities? Pharmalex is your ideal career destination! As one of the leading service providers in the pharmaceutical industry globally, Pharmalex specializes in all aspects of drug and medical device approvals, market development, and effective product maintenance.

Position: Senior Specialist - Platform Technologies (Argus)

Location: Noida/Mumbai, India (Hybrid)

Your Role

  • Consulting and Support:
    Provide direct consulting and support for Pharmalex’s Oracle Argus Hosted service, offering expertise in pharmacovigilance and safety database systems.

  • Training and Implementation:
    Assist in designing, developing, implementing, and improving technical solutions for the Pharmacovigilance business area, particularly focusing on the Argus rapidLIVE package.

  • System Management:
    Oversee system setup and configuration, create validation documentation, and develop training materials.

  • Project Management:
    Provide project management oversight for both client implementations and internal projects, ensuring alignment with defined policies and procedures.

  • Documentation and Compliance:
    Assist in developing and reviewing documents related to the Pharmacovigilance area, including SOPs and FAQs, ensuring compliance with regulatory standards.

  • Technical Updates:
    Deploy version updates, hot-fixes, and patches in accordance with controlled change request procedures.

  • Migration Support:
    Participate in designing and executing migrations for Oracle Argus.

  • Business Development:
    Contribute SME expertise to the business development process and engage in strategic initiatives as agreed with your supervisor.

Your Profile

  • Experience:
    3-5 years in the Life Sciences industry, with a focus on pharmacovigilance.

  • Education:
    Bachelor’s degree in Computer or Natural Science, or comparable education.

  • Technical Skills:
    Experience in Oracle Argus technical and functional support and familiarity with PL/SQL programming and database structures/models.

  • Validation Knowledge:
    In-depth understanding of computerized software validation (CSV), including GAMP 5 and 21 CFR Part 11.

  • GxP Experience:
    Experience working in GxP governed environments and information security controlled environments.

  • Project Management:
    Project management experience preferred.

  • Communication Skills:
    Strong communicator fluent in English, with the ability to work collaboratively and independently.

  • Organizational Skills:
    Highly organized, with strong attention to detail, analytical skills, and the ability to handle competing priorities.

  • Proactive Approach:
    Committed to continuous improvement for yourself, the Platform Technologies Team, and the Pharmalex organization.

How to Apply

If you are interested in this challenging opportunity at Pharmalex, we look forward to receiving your application. Please include your earliest possible starting date, any visa requirements, and salary expectations. Join us in shaping the future of pharmacovigilance!