Clinical Drug Safety Officer - Temporary

Grifols, S.A; Sant Cugat del Vallès; Hybrid; EUR 42,000 - 56,000; Full time

Benefits offered by this job

Hybrid Model

Flexible schedule

Job summary

Grifols, S.A invites a Clinical Drug Safety Officer for a temporary position. The role focuses on safety data collection, adverse event review, and acting as the pharmacovigilance representative for clinical studies. Strong communication and collaboration with clinical teams are essential.

You will contribute to safety management plans, DSUR/PSUR/RMP preparation, and support audits. Fluency in Spanish and English, plus a health sciences degree and CRO/pharma experience, are required.

Qualifications

• Bachelor’s degree in health sciences (pharmacy, nursing, medicine, veterinary) or bioscience (biochemistry, biotechnology, biology) or similar.
• 1 year’s experience in a similar position in a CRO or pharmaceutical company.
• Fluent in Spanish and English.
• High attention to detail with meticulousness.

Responsibilities

• Participate in safety data collection, review, processing, evaluation and compilation.
• Process adverse event case reports (mainly Serious Adverse Events from clinical trials) with follow-up and submissions per timelines.
• Provide technical oversight and be the pharmacovigilance representative for clinical studies.
• Subject Matter Expert for documents pertaining to clinical studies.
• Contribute to pharmacovigilance activities in collaboration with clinical teams and business partners.
• Develop safety management plans, SAE forms, safety reporting training, AE data reconciliation, and support regulatory inquiries.
• Contribute to benefit/risk assessment based on quality data management.
• Prepare Development Safety Reports (DSURs), PSURs and Risk Management Plans (RMPs).
• Create/update pharmacovigilance procedures and support audits/inspections.

Skills

Spanish fluency

English fluency

Attention to detail

Communication skills

Team player

Time management

Education

Health sciences degree

Job description

Clinical Drug Safety Officer - Temporary

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

• Participate in the safety data collection, review, processing, evaluation, analysis and compilation
• 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
• Provide technical oversight and be the pharmacovigilance representative for clinical studies
• Subject Matter Expert for documents pertaining to clinical studies
• Contribute to ensure compliance of pharmacovigilance activities with concerned departments such as clinical team or business partners
• 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
• Contribute to the assessment benefit/risk of medicines based in the highest quality data management
• Prepare Development Safety Reports (DSURs), and participate in the preparation of Periodic Update Reports (PSURs) and Risk Management Plans (RMPs)
• Create and/or update pharmacovigilance procedures and working practices
• Give support to pharmacovigilance staff involved in audits and inspections

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

• 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.

Information about Grifols is available at www.grifols.com.

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

Flexible schedule

Monday-Thursday 7-10 to 16-19h and Friday 8-15h. (with the same flexible start time).

Contract of Employment

Temporary position