ppWould 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. /p h3Mission /h3 pProvides operational support for global Pharmacovigilance (PV) activities for Grifols investigational and marketed products. Ensures Drug Safety, Pharmacovigilance deliverables are of the highest quality and meet global Regulatory Reporting timelines. Responsible for Safety Data Analysis, Data Review, and management of the integrated Safety Database utilized by worldwide Grifols pharmacovigilance personnel. /p h3What your responsibilities will be /h3 ul liTo participate in the safety data collection, review, processing, evaluation, analysis and compilation: ul liParticipate in the extraction, review and analysis of information from the pharmacovigilance database, performing Safety Information Analytics, Safety Data Analysis, Data Extraction, Data Review, and Data Management. /li /ul /li liCompilation and reconciliation of information in order to prepare documentation required by pharmacovigilance legislation: ul liProcess and review safety data to develop Aggregate Safety Reports. /li liSupport responses to requests from regulatory agencies, ensuring Regulatory Compliance.



/li liCoordinate and manage creation of SQL queries for Data Extraction used in different PV documents. /li liDevelop training documentation and/or work instructions to determine methods and procedures. /li liWork as Signal Analyst during Signal Detection and Signal Management activities, including extraction of signal detection reports and ensuring document filing and archiving. /li /ul /li liEnsure quality and compliance with the legal requirements for pharmacovigilance tasks and responsibilities: ul liSupport pharmacovigilance staff involved in audits and inspections (Quality Assurance, GVP Compliance). /li liProvide training to concerned personnel based on the training plan. /li liSupport the review and update of SOPs. /li liInteract with Regulatory Affairs Department regarding Aggregate Safety Reports and other documents required by Regulatory Authorities. /li /ul /li liPV database operating activities: ul liUse SQL queries for Data Extraction for different PV documents. /li liEnsure Data Consistency, Data Integrity, and Data Quality within the Safety Database. /li liSupport updates in the database configuration, collaborating with IT and Database Administration activities.



/li /ul /li /ul h3Who you are /h3 pTo 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). /p ul liBachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry), with a Master's or Postgraduate degree in the pharmaceutical sector and/or Pharmacovigilance, Bioinformatics, Biostatistics, or Data Analytics considered an asset. /li li1–2 years of experience in a similar position within the pharmaceutical industry (CRO or pharmaceutical company). /li liExperience with Excel, Excel Macros, SQL, Business Objects, RStudio, Data Analytics, or Business Intelligence tools is highly valued. /li liKnowledge of E2B(R2), E2B(R3), MedDRA, WHO Drug Dictionary, and medical terminology is considered an advantage. /li liAdvanced level of English. /li /ul h3What we offer /h3 pIt 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. /p h3Benefits package /h3 pbFlexibility for U Program /b: Hybrid Model. /p pbContract of Employment: /b Permanent position. /p pGrifols is an equal opportunity employer. /p /p #J-18808-Ljbffr

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