Operations Specialist 2 – Pharmacovigilance (Kolkata)
Job Summary:
IQVIA is seeking an experienced Operations Specialist 2 in Kolkata to lead pharmacovigilance operations, safety data review, and adverse event processing. The role involves mentoring junior staff, managing global safety data workflows, and ensuring compliance with regulatory standards. Candidates with 3–5 years of PV experience and expertise in safety databases will excel in this position.
Key Responsibilities:
Process safety data per global regulations, guidelines, SOPs, and project requirements.
Perform end-to-end pharmacovigilance activities: AE collection, coding, narrative writing, literature activities, case closure, and reconciliation.
Review safety data for regulatory reporting and liaise with authorities and stakeholders for expedited submissions.
Lead deliverables across Safety Publishing, Risk Management, and Safety Surveillance.
Train and mentor junior safety associates and support team performance.
Track project metrics, maintain project documentation, and ensure audit readiness.
Collaborate with cross-functional teams such as clinical, data management, and project management.
Participate in process improvement initiatives and lead operational training sessions.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences, Healthcare, or related field.
3–5 years of pharmacovigilance experience, including up to 3 years of safety data management.
Strong knowledge of medical terminology and global PV regulations.
Expertise in safety databases and Microsoft Office tools.
Excellent organizational, leadership, and project management skills.
Strong communication, mentoring, and decision-making abilities.
Ability to multitask, manage strict deadlines, and work effectively on multiple projects.
Flexibility to work in shifts and occasional travel.
Perks & Benefits:
Career growth with a global leader in pharmacovigilance and healthcare data solutions.
Hands-on exposure to international drug safety and regulatory practices.
Opportunity to mentor teams and lead critical PV projects.
Competitive salary and professional development programs.
Company Description:
IQVIA is a global leader in clinical research, pharmacovigilance, and healthcare analytics, providing data-driven solutions to accelerate drug development and improve patient outcomes. Through innovative technologies and global expertise, IQVIA supports life sciences companies worldwide.
Work Mode: On-site – Kolkata, India.
Call-to-Action:
Take the next step in your pharmacovigilance career. Apply now for the Operations Specialist 2 role at IQVIA in Kolkata and lead impactful drug safety initiatives.
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