Job
Description
Outpace Consulting Services is seeking an Aggregate Report Writer specializing in Pharmacovigilance (PV) Aggregate Reporting for a leading ITES company in the Life Sciences domain. In this role, you will be responsible for the end-to-end process of preparing, writing, and reviewing complex periodic aggregate safety reports (such as PBRER, PSUR, and DSUR). This involves meticulous planning, data interpretation, and ensuring strict compliance with client instructions, timelines, and industry regulations. Key Responsibilities: Report Planning & Preparation: Perform all pre-Data Lock Point (DLP) activities and comprehensive planning for all assigned reports. This includes conducting strategy meetings, kick-off meetings, and other ad hoc report-related discussions as per client instructions and timelines. Report Writing & Review: Prepare, write, and meticulously review the safety portions of various Periodic Aggregate Safety Reports (e.g., PBRER, DSUR, PSUR ). Compilation & Quality Control: Compile all global and country-specific periodic aggregate safety reports assigned by the supervisor. Conduct peer review of assigned reports and complete corresponding QC checklists within specified timelines. Timeline & Compliance Management: Track and drive the progress of safety periodic reports to ensure adherence to client-defined timelines. Ensure strict compliance with Standard Operating Procedures (SOPs), including client e-manuals and training modules, and all other process-related documentation. Data Interpretation: Understand and accurately interpret complex data and information, applying it practically within the reports. Required Qualifications: Experience: Minimum 2-3 years of medical writing work experience . 1-2 years of experience specifically in periodic aggregate safety report writing (e.g., PBRER, PSUR, DSUR). Skills: Working knowledge of MS Office applications . Good interpersonal, verbal, and written communication skills. Ability to understand and interpret data/information and its practical application. Knowledge: Knowledge of industry and business principles related to biopharmaceutical products and combination products. Work Ethic: Flexibility to work as per business requirements. To Apply: WhatsApp Hi to +91 9151555419 . Then, follow these steps: Click on the Start option to Apply and fill your details. Select the location as Other (to get multiple location options). For Mumbai , type: Job Code #54 For Pune , type: Job Code #55
