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Medical Reviewer - Aggregate Report

1-3 years
₹10–16 LPA
10 July 6, 2025
Job Description
Job Type: Full Time Education: MBBS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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