Medical Reviewer - Aggregate Report

As a Medical Reviewer at Sitero, you will play a crucial role in overseeing Pharmacovigilance (PV) and risk management activities related to drug safety services. Your responsibilities will include reviewing data for product-specific reports, providing medical oversight for draft reports, coordinating internal review processes, and finalizing reports from a medical perspective. You will collaborate with medical writers to address client comments and ensure the accuracy and compliance of all safety reports. Additionally, you will offer expert guidance in PV and aggregate reporting areas, manage post-marketing regulatory reporting and PV activities for assigned products, and prepare sections of medical significance for various aggregate safety reports. Your role will involve providing medical assessments, recommendations, and conclusions for Aggregate Safety Reports, as well as responding to adhoc regulatory queries with appropriate scientific interpretation. To excel in this position, you should have 1-3 years of clinical practice experience, including at least 1 year in Drug Safety and Pharmacovigilance within a pharmaceutical, biotech company, CRO, or regulatory agency. A Medical Degree (MBBS or higher) from a recognized medical school is required for this role. Your daily tasks will involve creating drug safety documents in accordance with SOPs and regulatory requirements, managing work efficiently to meet service level timelines, and ensuring the quality and accuracy of all medical documents. This role is permanent and full-time, with standard working hours of 40 hours per week, Monday to Friday, and a willingness to work in shifts when needed. Join Sitero's dynamic team and contribute to the safety and well-being of stakeholders in the clinical research community through your expertise and commitment to excellence in drug safety services.,