Medical Reviewer – Aggregate Report
Location: Mysore / Bangalore, Karnataka (Hybrid)
Department: Drug Safety Services
Employment Type: Full-time | Mid-level
Company Overview
Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. With deep expertise across diverse therapeutic areas, we focus on innovative, technology-enabled solutions that allow our clients to prioritize their core strengths. From early phase through Phase III clinical trials, we deliver high-touch services that ensure safety, ethics, compliance, and innovation across the clinical research community.
Role Summary
The Medical Reviewer will provide medical oversight and expertise in pharmacovigilance (PV) and aggregate reporting for both investigational and marketed products. This includes the preparation, review, and finalization of aggregate safety reports, benefit-risk assessments, and responses to regulatory queries.
Key Responsibilities
Pharmacovigilance & Risk Management
Oversee PV and risk management activities for assigned products.
Provide medical input into aggregate safety reports (e.g., PSUR, PBRER, PADER, DSUR, RMP).
Conduct medical assessments, recommendations, and conclusions for safety documents.
Coordinate post-marketing regulatory reporting and PV activities.
Aggregate Report Preparation
Draft and review single/aggregate/cumulative medical assessments in compliance with SOPs/WIs.
Provide expert review of finalized reports even if involved in their drafting.
Collaborate with medical writers to address client comments and finalize reports.
Ensure accurate scientific interpretation of data for inclusion in drug safety documents.
Regulatory Support
Prepare responses to ad-hoc regulatory queries.
Maintain compliance with applicable regulations, SOPs, and conventions.
Operational Management
Plan, organize, and manage workload to meet service level timelines.
Support continuous improvement in PV and aggregate reporting processes.
Qualifications
Medical degree (MBBS or higher) from a recognized medical school.
1–3 years’ experience in clinical practice.
1+ years’ experience in drug safety / pharmacovigilance (pharma, biotech, CRO, or regulatory agency preferred).
Strong understanding of PV regulations and aggregate reporting requirements.
Key Skills
Medical writing and data interpretation.
Knowledge of aggregate reporting standards.
Strong organizational and time management abilities.
Collaborative mindset and clear communication skills.
Compensation & Benefits
Competitive salary with variable pay.
Paid time off.
Healthcare and retirement benefits.
Work Schedule
40 hours/week, Monday–Friday (1-hour lunch break).
Willingness to work shifts when required.
Estimated Salary Range: ₹10 – ₹18 LPA (based on experience)
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