Medical Reviewer – Aggregate Report
Drug Safety Services
Mysore (Hybrid Work Model)
Also listed as Bangalore, Karnataka – Hybrid
Sitero
Full-Time | Permanent
Standard: Monday to Friday, 40 hours/week
Lunch Break: 1 hour
Flexibility: Must be willing to work in shifts when needed
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.
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.
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.
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.
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.
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.
Medical Degree (MBBS or higher) from a recognized institution.
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.
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
Competitive salary
Variable pay structure
Paid time off
Healthcare benefits
Retirement benefits
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.
Interested candidates can apply via the Sitero Careers Page or relevant job portal where the position is listed.
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