Medical Reviewer - Aggregate Report

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. OVERSIGHT OF PHARMACOVIGILANCE (PV) AND RISK MANAGEMENT ACTIVITIES: - Review all appropriate data for product specific reports. - Provide draft and review (carried out by separate individuals) all single/aggregate/cumulative medical assessments/benefit risk assessments for safety reports. - Provide medical oversight white creating draft reports based on the approved SOP/WI process. - Coordinate internal review process and finalize draft reports from medical point of view. - Assist medical writer in addressing all comments from client and finalize. - Should review the finalized report even if participated in assisting medical writer. - Provide expert guidance in PV and Aggregate reporting areas. - Coordinate all post marketing regulatory reporting and PV activities for assigned products to be carried out by Sitero aggregate reporting team. - Preparation of sections of medical significance/inputs for aggregate safety reports such as PSUR, PBRER, Periodic Adverse Drug Experience Report (PADER), Summary Bridging Report, Addendum to Clinical Overview, DSUR, RMP, and addendum to PSUR. - Responsible for the medical assessment, recommendation, and conclusion section of the Aggregate Safety Reports. - Prepare and review responses to adhoc regulatory queries. - Appropriate scientific interpretation of relevant information for inclusion into drug safety documents, prepare and write analytical aggregate reports and other drug safety medical documents. - Creating all documents in accordance with applicable Standard Operating Procedure (SOPs), conventions, and regulatory requirements. - Planning, organizing, and managing daily work to meet service level timelines and deliverables.

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.