Technical Drug Safety Officer

Grifols; Barcelona; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

Grifols in Barcelona, Spain, is hiring a Technical Drug Safety Officer to join our global pharmacovigilance team. You will support safety data collection, processing and reporting for Grifols investigational and marketed products, ensuring high quality deliverables and regulatory timelines.

The ideal candidate holds a Bachelor’s in Health Sciences (Pharmacy/Biology/Chemistry), with 1–2 years in pharma, and strong English plus proficiency in MS Office and SAP.

Competenze

• Bachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry) and ideally a Master or Postgraduate in pharma/PV.
• 1–2 years of experience in a similar pharma role (CRO or company) is highly valued.
• Knowledge of MS Office and SAP; advanced English.

Mansioni

• Participate in safety data collection, review, processing, evaluation and compilation.
• Process adverse event reports for marketed products and conduct follow-up with reporters.
• Prepare documentation for PV legislation and regulatory reporting timelines.
• Review weekly literature and PV legislation updates; ensure archiving compliance.
• Prepare periodic safety update reports; ensure data quality and database integrity.
• Support audits and inspections and provide PV training as needed.

Conoscenze

Advanced English

PV knowledge

Formazione

Bachelor’s in Health Sciences

Master in pharmaceutical sector

Strumenti

MS Office

SAP

Descrizione del lavoro

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.

Your role mission: Provides operational support for global pharmacovigilance activities for Grifols investigational and marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for data reviews and management of the integrated database utilized by worldwide Grifols pharmacovigilance personnel.

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 submissions required and conducting follow-up with reporters).
• Compilation and reconciliation of information in order to prepare documentation required by pharmacovigilance legislation:
• Review of the weekly literature review.
• Review of the updates in pharmacovigilance legislation.
• Compliance with archiving tasks for deliverables and relevant documents.
• Compilation of information for and participation in preparation of periodic safety update reports.
• Ensure quality and compliance with the legal requirements for pharmacovigilance tasks and responsibilities:
• Support to the pharmacovigilance staff involved in audits and inspections
• Provide training to concerned personnel based on the training plan and managing training documentation and deliverables within relevant company departments
• Support to the review and update of the SOPs, working practices or conventions
• PV database operating activities:
• Use of queries for data extraction for different PV documents.
• Ensure data consistency and integrity within the safety database.
• Support to updates in the database configuration..

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).

• Bachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry), being valuable to have a Master or Postgraduate degree in the pharmaceutical sector and/or in Pharmacovigilance.
• You have 1-2 experience in a similar position within pharma industry (CRO or pharmaceutical company), being high valuable.
• You have knowledge of MS Office and SAP program.
• You have advanced level of English.

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.