CLINICAL DRUG SAFETY OFFICER (San Cugat del Vallés)

CLINICAL DRUG SAFETY OFFICER (San Cugat del Vallés)

29 ago
|
Grifols
|
San Cugat del Vallés

29 ago

Grifols

San Cugat del Vallés

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 general 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

📌 CLINICAL DRUG SAFETY OFFICER (San Cugat del Vallés)
🏢 Grifols
📍 San Cugat del Vallés

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