Medical Reviewer - Aggregate Report

As a Medical Reviewer at Sitero, an emerging leader in Clinical services and software solutions for the life sciences industry, your role will involve overseeing overall Pharmacovigilance (PV) and risk management activities. You will be responsible for reviewing all appropriate data for product-specific reports and providing draft and review for medical assessments and benefit-risk assessments for safety reports. Your duties will also include providing medical oversight while creating draft reports based on approved SOP/WI processes, coordinating internal review processes, and finalizing draft reports from a medical point of view. Key Responsibilities: - Oversee overall Pharmacovigilance (PV) and risk management activities. - Review all appropriate data for product-specific reports. - Provide draft and review for medical assessments/benefit-risk assessments for safety reports. - Provide medical oversight while creating draft reports based on approved SOP/WI processes. - Coordinate internal review processes and finalize draft reports from a medical point of view. - Assist medical writer in addressing all client comments and finalizing reports. - Provide expert guidance in PV and Aggregate reporting areas. - Coordinate post-marketing regulatory reporting and PV activities for assigned products. - Prepare sections of medical significance/inputs for aggregate safety reports. - Responsible for the medical assessment, recommendation, and conclusion section of the Aggregate Safety Reports. - Prepare and review responses to adhoc regulatory queries. - Scientific interpretation of relevant information for inclusion into drug safety documents. - Create documents in accordance with applicable SOPs, conventions, and regulatory requirements. - Plan, organize, and manage daily work to meet service level timelines and deliverables. Qualifications Required: - 1-3 years of experience in Clinical Practice required. - 1+ year of experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO, or regulatory agency. - Medical Degree (MBBS or higher) from a recognized medical school. In this role, you will be required to work full-time with standard hours of 40 hours per week, Monday to Friday, with additional hours as needed. You should be willing to work in shifts as and when required. (Note: Compensation & Benefits details and additional company information are not provided in the job description.),