Job Title: Operations Specialist 2 - India
Department: Lifecycle Safety
Location: Thane, Maharashtra
Job Type: Full-Time
Application End Date: 9 May 2025
Job Overview:
The Operations Specialist 2 applies expertise in safety data management and pharmacovigilance to review, assess, and process complex safety information. This role involves decision-making, regulatory reporting, team mentorship, and client communication while ensuring project compliance and quality standards.
Key Responsibilities:
Process safety data in line with applicable regulations, guidelines, SOPs, and project requirements.
Conduct pharmacovigilance activities, including:
Collecting and tracking adverse events (AE) and endpoint data
Determining event status (initial/update)
Database entry, AE and product coding, narrative writing, and literature handling
Execute quality review, reconciliation, case closure, and translation coordination tasks.
Perform adjudication-related activities and assess safety data for reportability.
Liaise with regulatory authorities and stakeholders to ensure timely reporting and compliance.
Contribute to or lead Safety Publishing, Risk Management, Medical Information, and other service line deliverables.
Support training and mentoring for junior staff; serve as backup to Operations Manager as needed.
Maintain detailed knowledge of project scope, protocol, budget, and status metrics.
Establish strong communication with internal teams and external stakeholders.
Ensure 100% compliance with training and SOP acknowledgment requirements.
Participate in department initiatives, process efficiency projects, and audits.
May perform medical review of non-serious AEs/ADRs, ensuring data completeness and regulatory alignment.
Required Qualifications:
Education: Bachelor's degree in life sciences, healthcare, or related field (Required)
Experience: Up to 5 years of relevant experience, including 3 years in Pharmacovigilance (Required)
Preferred: Equivalent education/training/experience combinations
Key Skills & Competencies:
Strong understanding of medical terminology and global regulatory requirements
Proficiency in safety databases and client/internal applications
Excellent project management, organizational, and time management skills
High attention to detail, quality, and accuracy
Advanced communication, leadership, and mentoring abilities
Ability to multitask, meet strict deadlines, and manage team priorities
Flexible, self-motivated, with sound judgment and problem-solving skills
Team-oriented with a commitment to departmental goals and quality deliverables
Willingness to work in shifts and travel as required
Company Profile:
IQVIA is a global leader in clinical research, healthcare analytics, and technology services. It connects data and science to help accelerate medical innovations and improve health outcomes. Learn more at jobs.iqvia.com.
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