Medical Reviewer – Aggregate Report
Location: Bangalore, Karnataka (Hybrid)
Department: Drug Safety Services
Employment Type: Full Time | Mid-Level
About Sitero:
Sitero is a rising leader in clinical services and software solutions for the life sciences industry. With a strong focus on ethics, compliance, and innovation, Sitero supports early to late-phase clinical trials with a range of high-touch services and advanced technology, ensuring safety across all clinical research stakeholders.
Position Overview:
The Medical Reviewer – Drug Safety is responsible for providing medical oversight, expert guidance, and scientific interpretation for a range of aggregate safety reports, including PSURs, PBRERs, PADERs, DSURs, and others. The role includes ensuring scientific accuracy, regulatory compliance, and timely delivery of high-quality safety documents.
Key Responsibilities:
Medical Review & Oversight:
Oversee pharmacovigilance (PV) and risk management activities for assigned products.
Review all relevant clinical and safety data in support of product-specific aggregate safety reports.
Draft and review medical sections of aggregate reports and benefit-risk assessments.
Provide medical oversight during the report drafting process according to SOPs/WIs.
Finalize and approve safety reports from a medical perspective.
Collaboration & Coordination:
Support and guide medical writers in drafting and revising documents based on client and internal feedback.
Review finalized reports even if involved in earlier stages of the writing process.
Work closely with cross-functional teams to coordinate all post-marketing safety reporting activities.
Provide expert input in responding to regulatory authority queries and ad-hoc requests.
Documentation & Compliance:
Prepare and review medically significant sections of various reports:
PSUR, PBRER, PADER, DSUR, RMP, Summary Bridging Reports, Addendum to Clinical Overviews.
Ensure all safety documentation is compliant with regulatory standards and company SOPs.
Assist in scientific interpretation and data integration for analytical and cumulative safety reports.
Qualifications & Experience:
Education: MBBS or higher from a recognized medical school.
Experience:
1–3 years of clinical practice is required.
Minimum 1 year of pharmacovigilance or drug safety experience in a pharmaceutical company, CRO, or regulatory agency is preferred.
Experience with both investigational and marketed products is a plus.
Compensation & Benefits:
Competitive salary with variable pay.
Healthcare and retirement benefits.
Paid time off.
Permanent, full-time role.
Working Hours & Commitments:
Standard: 40 hours/week (Monday to Friday), 1-hour lunch break.
Flexibility: Willingness to work in shifts as needed.
Estimated Salary: ₹10–16 LPA
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