Job Title: Operations Specialist 2
Department: Lifecycle Safety
Location: Thane, Maharashtra
Job Type: Full-Time
Application Deadline: 9 May 2025
Job Overview:
The Operations Specialist 2 applies advanced knowledge and expertise to process, assess, and review safety data across service lines, functioning as a recognized subject matter expert. This role includes providing oversight on small to medium operational projects, mentoring junior staff, and ensuring compliance with applicable regulatory and project standards.
Key Responsibilities:
Pharmacovigilance & Safety Data Processing:
Execute pharmacovigilance activities including AE/endpoint data collection, tracking, coding, and database entry.
Write narratives, manage literature-based activities, quality checks, translations, and reconciliation tasks.
Assess data for reportability and coordinate with stakeholders for timely submissions to regulatory bodies.
Operational Oversight & Project Contribution:
Lead or contribute to deliverables across Safety Publishing, Risk Management, Medical Information, or related service lines.
Support adjudication and case closure as required.
Monitor metrics, productivity, and performance for assigned projects.
Ensure thorough understanding of project protocols and scope.
Team Collaboration & Communication:
Maintain effective communication with project management, clinical, and data teams.
Serve as point of contact for clients regarding daily case processing.
Provide training, feedback, and mentorship to junior team members.
Participate in internal initiatives and process improvement projects.
Compliance & Documentation:
Ensure 100% compliance with SOPs, training plans, and project-specific requirements.
Maintain accurate documentation for training, communication, and project files.
Support audit preparedness and contribute to departmental goals.
Additional Duties:
Lead and support team initiatives and meetings.
Perform medical review of non-serious AEs/ADRs if applicable.
Act as a backup for Operations Manager as needed.
Qualifications & Experience:
Education: Bachelor’s Degree in Life Sciences, Healthcare, or related discipline (required).
Experience:
Up to 5 years in pharmacovigilance, including 3 years minimum in relevant roles.
Proven experience in mentoring, coaching, and project oversight.
Skills & Competencies:
Strong command of medical terminology and safety databases.
Advanced knowledge of global and local clinical research regulations.
Proficiency in Microsoft Office and web-based platforms.
Excellent attention to detail, time management, and communication skills.
Capable of independent work, multitasking, and decision-making.
Strong interpersonal, negotiation, and leadership skills.
Demonstrates IQVIA core values and adheres to compliance standards.
Willingness to work in shifts and travel occasionally.
For more information, visit: IQVIA Careers
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