Senior Programming Analyst

This is a fully remote position, open to applicants in India.

📋 Description

• Validation of -PV system upgrades/hot fixes, client-specific ad-hoc reports, gateway setups, and data migrations tailored to client needs.

• Aids the department by developing metrics reports and techniques aimed at enhancing process efficiencies and overall business performance.

• Acts as the validation point of contact for the most challenging and intricate PV projects.

• Functions as a consultant for the PV department.

• Contributes to resource allocation and project estimation discussions.

• Reviews processes and provides recommendations for development and improvement.

• Utilizes new AI capabilities to enhance team efficiencies.

• Facilitates requirements gathering sessions with business stakeholders, translating their needs into detailed functional and technical specifications.

• Analyzes requirements and collaborates with development teams to ensure accurate conversion into system design specifications, reports, and validated solutions.

• Independently plans, authors, and executes System Integration Testing (SIT), User Acceptance Testing (UAT), and Performance Qualification (PQ) protocols and scripts for validated GxP systems.

• Validates custom programs, listings, reports, and system enhancements in alignment with regulatory requirements and company procedures.

• Acts as a subject matter expert (SME) for CSV activities, ensuring that validation deliverables are developed, reviewed, approved, and maintained in compliance with applicable SOPs, industry regulations, and quality standards, including GxP and 21 CFR Part 11 requirements.

• Initiates continuous improvement projects by identifying opportunities to streamline, standardize, and automate business processes, thereby enhancing operational efficiency, compliance, and data integrity.

• Authenticates and maintains high-quality validation and SDLC documentation, including Validation Plans, Requirements Specifications, Risk Assessments, Test Protocols, Traceability Matrices, Validation Summary Reports, and change control documentation.

• Develops and delivers end-user training, knowledge transfer sessions, and relevant supporting documentation.

• Contributes to the creation and revision of SOPs, Work Instructions, and best practices to facilitate validated system operations.

• Establishes best practices documents based on lessons learned from previous deliveries and applies them to future validation projects.

• Investigates and resolves complex system issues, performing impact assessments, root cause analysis, and validation of corrective actions, enhancements, and system fixes in collaboration with business and technical teams.

• Participates in client vendor calls regarding validation activity scope discussions and status updates.

• Keeps abreast of evolving regulatory expectations, validation methodologies, industry trends, and emerging technologies related to Computer System Validation and Pharmacovigilance systems.

• Mentors junior team members and shares best practices across the organization.

• Assists during regulatory inspections, client audits, and internal quality audits by providing necessary validation documentation.

⛳️ Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification.

• Prior experience that equips the candidate with the knowledge, skills, and abilities to perform the job effectively (around 5+ years preferred).

• Familiarity with CSV and Oracle Argus Safety system is a plus.

• Extensive understanding of Pharmacovigilance processes including relevant SOPs, ICH GCP, current pharmacovigilance regulations, and local guidelines.

• Strong attention to detail.

• Excellent problem-solving and innovative capabilities.

• Proficient written and verbal communication skills to effectively interact with teams and clients, including fluency in English.

• Ability to independently organize and manage multiple tasks with demanding timelines.

• Capacity to adapt to changing priorities.

• Effective communication skills within a multi-disciplinary team.

• Proven ability to complete assigned tasks on time and within budget.

• Demonstrated positive attitude, enthusiasm for work, and ability to collaborate well with others.

🏝️ Benefits

• Work is conducted in a remote environment with necessary electrical equipment provided.