Please note: the service contract for this position will not be concluded with Boehringer Ingelheim International GmbH but with GULP Consulting Services GmbH

Boehringer Ingelheim

Medical Consultant (m/f/n)

Posted Aug 5, 2022
Project ID: BIJP00000840
Location
Ingelheim am Rhein
Duration
6 months
(Sep 1, 2022 - Feb 28, 2023)
Hours/week
20 hrs/week
Payrate range
Unknown

Risk Management in Patient Safety & Pharmacovigilance

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.

The contractor will independently provide the following services based on the contractors expertise and considering methods as defined in regulatory and BI guidelines:

-   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.


The following timelines are to be adhered to by the contractor during the performance of the service:
Regulatory timelines of documents and task related to the Immunology and Ofev/IPF/ILD product families

Similar projects

+ Search all projects