Sharath Kumar R

Role Overview.

The Operations Specialist will be responsible for ensuring the highest standards of drug safety and compliance throughout clinical trials and post-marketing phases. This role involves quality review of safety reports, stakeholder training, deviation management, and effective communication with internal and external teams.

• Quality Review: Perform a comprehensive quality review of Individual Case Safety Reports (ICSRs), including all report types from clinical trials and post-marketing, with a special focus on SUSARs.
• Unblinding Cases: Manage the unblinding of clinical trial cases using Interactive Response Technology (IRT).
• Compliance Monitoring: Maintain compliance reports related to training, timesheets, and case quality.
• Training and Communication: Provide training to stakeholders and vendors during transitions, and communicate updates via email and scheduled calls.
• Deviation Management: Handle deviation management (CAPA), and prepare late case analysis reports.
• Knowledge Sharing: Conduct knowledge-sharing sessions based on updates and late case analysis findings.
• Workflow Coordination: Attend workflow meetings, schedule, and participate in client calls as per requirements.
• Mentorship: Mentor new joiners, and oversee the completion of accreditation processes.
• Query Management: Initiate and close queries in Electronic Data Capture (EDC) systems; send follow-up and escalation requests to sites.

• Strong understanding of pharmacovigilance processes and regulatory requirements.
• Expertise in ICSR review and SUSAR handling.
• Proficiency in IRT and EDC systems.
• Excellent communication and stakeholder management skills.
• Ability to manage CAPA and deviation processes effectively.
• Leadership and mentoring capabilities.
• Detail-oriented, with strong analytical and problem-solving skills.

Role Overview

The Junior Quality Analyst will be responsible for ensuring accuracy, consistency, and compliance in labeling and packaging content for pharmaceutical products. This role involves proofreading, copy editing, and quality checks of various artwork components to meet regulatory and branding standards.

Key Responsibilities

• Proofreading and Quality Checks: Review and proof a variety of artworks, including medicinal information cartons, foils, leaflets, and stickers.
• Editorial: Consistency: Ensure plain language, grammar, brand voice, regulatory compliance, and design standards across high-profile design, copywriting projects, and marketing communication materials.
• Labeling Comparison: Compare source labeling to reformatted content, and/or proofread prior to approval and printing of final secondary packaging components.
• Copy Editing: Perform content checks and copy-editing activities to ensure labeling quality before final sign-off.
• Final Review & Approval: Conduct final editing and provide sign-off on projects before release for publishing.
• Error Identification: Read proof against the copy using standardized codes to mark grammatical or typographical errors, and verify corrections against the original copy.
• Design Verification: Measure the spacing and positioning of page elements to ensure adherence to branding and style guidelines.
• Proof Management: Mark errors using standardized proofreading marks, return the marked proof for correction, and check the corrected proof against the original copy.
• Document Preparation: Create PDF documents of approved work, and forward them to clients for review and SEC filing.

Technical Skills.

• ALIM Operations for internal and external processes.
• Kodak smart review system
• TVT (Text Verification Tool)
• Proof comparison tool
• Adobe Photoshop.

Required Skills and Competencies.

• Strong attention to detail and accuracy in proofreading and editing.
• Knowledge of regulatory compliance and branding guidelines.
• Proficiency in proofreading tools and design software.
• Ability to manage multiple projects and meet deadlines.
• Excellent communication and collaboration skills.