Global Pharmacovigilance & Drug Safety Trainee

Esteve; Barcelona; Hybride; EUR 42 000 - 60 000; Plein temps

Résumé du poste

Grifols seeks a Technical Drug Safety Officer to join our international team. You will participate in safety data collection, review and compilation, and manage adverse event reports within regulatory timelines.

You will provide pharmacovigilance oversight for clinical studies and contribute to safety plans and reporting, ensuring compliance across departments. The role requires a health sciences degree and at least 1 year in a CRO or pharmaceutical setting, with fluency in Spanish and English.

Qualifications

• Bachelor's degree in health sciences (pharmacy, nursing, medicine, veterinary) or bioscience or similar.
• 1 year's experience in a similar position in a CRO or a pharmaceutical company.
• Fluent in Spanish and English.

Responsabilités

• Participate in safety data collection, review, processing, evaluation and compilation.
• Process adverse event case reports (mainly Serious Adverse Events) and ensure regulatory timelines.
• Provide pharmacovigilance oversight for clinical studies and act as Subject Matter Expert for clinical study documents.
• Contribute to safety management plans, SAE design, training and data reconciliation.
• Prepare DSURs, PSURs and Risk Management Plans and support inspections and audits.

Connaissances

Attention to detail

Excellent communication

Team player

Formation

Bachelor's degree in health sciences or bioscience

Description du poste

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 global 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 (RMPs)
• You will create and/or update pharmacovigilance procedures and working practices
• You will give support to pharmacovigilance staff involved in audits and inspections

Who you are

• You have a Bachelor's Degree in health sciences (pharmacy, nursing, medicine, veterinary) or bioscience (biochemistry, biotechnology, biology) or similar
• You have 1 year's experience in a similar position in a CRO or a pharmaceutical company
• You speak fluent Spanish and English
• You are attention to detail and meticulousness
• You have excellent communication skills with different internal and external stakeholders
• You have planning skills and organized work habits
• You have ability to work as part of a team
• You have ability to work on multiple projects simultaneously, manage priorities and work under pressure

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.

Grifols is an equal opportunity employer.

Flexibility for U Program : Hybrid Model.Benefits packageContract of Employment Permanent position.Location Sant Cugat del Vallès.

more about Grifols

Type Indefinido tiempo completoJob Category I + D

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 global 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.

Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a _Technical Drug Safety Officer_ like you.

What your responsibilities will be

• To participate in the safety data collection, review, processing, evaluation, analysis and compilation:
• Processing Grifols marketed products adverse event case reports (including definition of