For one of our clients in the pharma industry we’re looking for a freelance Medical Consultant: Project description: The service is requested as part of the project Risk Management in Patient Safety & Pharmacovigilance. The project has the purpose to achieve regulatory compliance in the field of pharmacovigilance evaluating the safety profile of BI drugs. With the goal to fulfil submission timelines of periodic reports delivering safety information such as Development Safety Update Reports (DSUR), in Periodic Benefit-Risk Evaluation Reports (PBRERs) as defined in regulations.
Medical evaluation of individual case safety reports and aggregated safety data (data and information will be provided by BI) and preparation of safety signal assessment reports.
Preparation and input, review and implementation of comments to sections in Periodic Benefit-Risk Evaluation Reports (PBRERs) concerning aggregated post-marketing safety data. (Ofev PBRERs with aggregate analyses of safety data from post-marketing sources)
Preparation and input, review and implementation of comments to sections in Periodic Benefir-Risk Evaluation Reports (DSURs) concerning aggregated safety data. (Immunology and Ofev/IPF/ILD product families DSURs with aggregate analyses of safety data)
Create Ofev and spesolimab Risk Management Plans and Addendum to Clinical Overview with aggregate analyses of safety data from clinical trial and post-marketing sources. Deliverables: input, review and implementation of comments to sections in Risk Management Plans and Addendum to Clinical Overview concerning aggregated clinical trial and post-marketing safety data.
Create Immunology and Ofev/IPF/ILD product families signal assessment reports.
Professional Consulting for the preparation of periodic safety reports
Professional Consulting for the preparation of interim or final study reports
Professional Consulting to safety-related content of marketing authorisation applications (Summary of Clinical Safety, Clinical Overview)
Prepare safety responses for requests from various Health authorities
For all above described tasks, the freelancer will prepare drafts and provide it to BI for review and discussion. Based on the reviews outcome, the contractor will adapt the forms accordingly. The performance of the contractor has the goal to provide a medical safety expertise in order to achieve regulatory compliance in the field of pharmacovigilance. Skills:
Qualification: medical doctor
Language: English fluent
Experience (at least 4 years) performing signal detection and safety surveillance/safety data analysis for pharmaceutical products; ideally including products in clinical development
Project start: September 2022 Project location: Ingelheim am Rhein (Project is 95% remote) Project duration: 6+ months Project capacity: 20 hrs./week (5 hrs./day)