07 sep
|
Grifols
|
Madrid
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a integral healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.
What Your Responsibilities Will Be
You will participate in the safety data collection, review, processing, evaluation, analysis and compilation
You will process adverse event case reports (mainly Serious Adverse Events from clinical trials) and conduct follow‑up, including definition of submissions to ensure compliance with regulatory agencies timelines for individual case reports
You will provide technical oversight and be the pharmacovigilance representative for clinical studies
You will be Subject Matter Expert for documents pertaining to clinical studies
You will contribute to ensure compliance of pharmacovigilance activities with concerned departments such as clinical team or business partners
You will conduct clinical pharmacovigilance activities such as development of safety management plans, develop and design the SAE forms, provide safety reporting training for appropriate parties, reconciliation of AE data, participate in on‑going/final clinical trial safety data reviews and support to respond to requests from regulatory agencies
You will contribute to the assessment benefit/risk of medicines based in the highest quality data management
You will prepare Development Safety Reports (DSURs), and participate in the preparation of Periodic Update Reports (PSURs) and Risk Management Plans (
📌 CLINICAL DRUG SAFETY OFFICER (Madrid)
🏢 Grifols
📍 Madrid