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Medical Reviewer – Aggregate Report

1–3 years years
Not Disclosed
10 Sept. 1, 2025
Job Description
Job Type: Hybrid Education: Medical Degree (MBBS or higher) from a recognized institution 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

Job Title:

Medical Reviewer – Aggregate Report


Department:

Drug Safety Services


Location:

Mysore (Hybrid Work Model)
Also listed as Bangalore, Karnataka – Hybrid


Company:

Sitero


Employment Type:

Full-Time | Permanent


Work Hours:

  • Standard: Monday to Friday, 40 hours/week

  • Lunch Break: 1 hour

  • Flexibility: Must be willing to work in shifts when needed


About Sitero:

Sitero is a growing leader in clinical services and software solutions for the life sciences industry. The company supports early phase through Phase III clinical trials with technology-enabled solutions, emphasizing ethics, compliance, innovation, and patient safety. Services are delivered by an experienced team across a wide range of therapeutic areas.


Job Summary:

The Medical Reviewer will be responsible for providing medical oversight and evaluation in pharmacovigilance and aggregate safety report preparation. This role requires close collaboration with cross-functional teams and medical writers to ensure regulatory compliance and high-quality safety data analysis.


Key Responsibilities:

Medical Review & Oversight

  • Oversee all Pharmacovigilance (PV) and risk management activities.

  • Perform medical assessments for single case and aggregate/cumulative reports.

  • Ensure medical accuracy and consistency in all product-specific reports.

  • Provide medical review for all draft and final safety documents.

Report Development

  • Create and review safety sections for reports such as:

    • PSUR, PBRER

    • PADER, DSUR

    • RMP, Addendum to PSUR, Summary Bridging Reports, etc.

  • Draft medical conclusions, recommendations, and benefit-risk assessments.

  • Assist medical writers in addressing client feedback and comments.

  • Finalize reports from a medical point of view.

Regulatory & Compliance

  • Respond to regulatory authority queries.

  • Ensure all documents comply with SOPs, regulatory requirements, and industry standards.

  • Provide scientific interpretation and summarization of complex safety data.

Collaboration & Coordination

  • Coordinate post-marketing regulatory activities.

  • Work closely with internal teams to meet service-level timelines.

  • Guide cross-functional teams with expertise in pharmacovigilance and aggregate reporting.


Required Qualifications:

Education:

  • Medical Degree (MBBS or higher) from a recognized institution.

Experience:

  • 1–3 years of clinical practice (mandatory).

  • 1+ year experience in Drug Safety / Pharmacovigilance, preferably in:

    • Pharmaceutical or biotech company

    • Contract Research Organization (CRO)

    • Regulatory agency

  • Experience handling both investigational and marketed products is a plus.


Key Skills & Competencies:

  • Strong medical writing and review capabilities

  • Familiarity with global pharmacovigilance requirements

  • Analytical thinking and scientific interpretation

  • Collaboration and team management

  • Deadline-driven and detail-oriented


Compensation & Benefits:

  • Competitive salary

  • Variable pay structure

  • Paid time off

  • Healthcare benefits

  • Retirement benefits


Additional Information:

Equal Opportunity:

Sitero is an equal opportunity employer. All qualified applicants will be considered without regard to race, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other legally protected characteristics.


How to Apply:

Interested candidates can apply via the Sitero Careers Page or relevant job portal where the position is listed.