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Specialist IS Bus Sys Analyst - Signal & Risk Management

Specialist IS Bus Sys Analyst - Signal & Risk Management

ConfidentialHyderabad / Secunderabad, Telangana
26 days ago
Job description

Work with partners to identify and prioritize system enhancements and new functionalities to meet evolving business needs

  • Responsible for defining and implementing project and technical roadmaps that align with the strategy.
  • Find opportunities for automation and process improvements within the Safety ecosystem.
  • Overall accountability for technical implementation aspects of projects, including planning, architecture, design, development, and testing, to follow IS Change Control and GxP validation processes.
  • Work closely with delivery and platform teams to ensure applications align with approved architectural and development guidelines.
  • Identify data patterns to support informed decision-making. Collect, analyze, and interpret data to identify trends, insights, and areas for improvement.
  • Keep updated on industry trends, emerging trends, and standard processes for pharmacovigilance systems.
  • Lead and contribute to business case development, workshops, and RFPs.
  • Responsible for supporting and leading technical root cause analysis and works with vendors to resolve Pharmacovigilance system-related issues.
  • Responsible for improving performance by coaching, mentorship, and training to develop both technical and professional skills within the team.
  • Support audits and inspections.

Basic Qualifications and Experience :

  • Master's degree with 4 - 6 years of experience in Computer Science, IT, or a related field OR
  • Bachelor's degree with 6 - 8 years of experience in Computer Science, IT, or a related field OR
  • Diploma with 10 - 12 years of experience in Computer Science, IT, or a related field.

    • Must-Have Skills :

  • 3+ years of experience with COTS Pharmacovigilance Platforms (e.g., Argus) or other safety databases.
  • Extensive expertise in SDLC, including requirements, design, testing, data analysis, and change control.
  • Experienced in Agile project methodologies and working in Product Teams using JIRA.
  • Experience or demonstrable understanding of Computer Systems Validation, including FDA 21 CFR Part 11, GxP Compliance, and change control.
  • Strong communications skills in writing, speaking, communicating, and time management.
  • High learning agility, problem-solving, and analytical thinking skills.
  • Experience in requirements gathering and process improvement.

    • Good-to-Have Skills :

  • Ability to work in a fast-paced and dynamic environment.
  • Able to communicate technical or complex subject matters in business terms.
  • Outstanding written and verbal communication skills, and ability to explain technical concepts to non-technical clients.
  • Experience with Safety Signal and Risk Management platforms is a plus.
  • Experienced in database programming languages and data modeling concepts, including Oracle SQL and PL / SQL.

    • Professional Certifications :

  • SAFe for Teams certification (preferred).

    • Soft Skills :

  • Excellent analytical and troubleshooting skills.
  • Excellent leadership and strategic thinking abilities.
  • Strong verbal and written communication skills.
  • Ability to work effectively with global, virtual teams.
  • High degree of initiative and self-motivation.
  • Ability to manage multiple priorities successfully.
  • Team-oriented, with a focus on achieving team goals.
  • Strong presentation and public speaking skills.
  • Ability to deal with ambiguity and think on their feet.
  • Ability to influence and drive to an intended outcome.
  • Ability to hold team members accountable to commitments.

    • Skills Required

    Sql, Project Management, Pharmacovigilance, Troubleshooting, Computer System Validation, Sdlc

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    Analyst • Hyderabad / Secunderabad, Telangana