09 oct
|
Grifols
|
Madrid
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 integral 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 BeYou will participate in the safety data collection, review, processing, evaluation, analysis and compilationYou 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 reportsYou will provide technical oversight and be the pharmacovigilance representative for clinical studiesYou will be Subject Matter Expert for documents pertaining to clinical studiesYou will contribute to ensure compliance of pharmacovigilance activities with concerned departments such as clinical team or business partnersYou 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 agenciesYou will contribute to the assessment benefit/risk of medicines based in the highest quality data managementYou 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 practicesYou will give support to pharmacovigilance staff involved in audits and inspectionsWho You AreYou have a Bachelor’s Degree in health sciences (pharmacy, nursing, medicine, veterinary) or bioscience (biochemistry, biotechnology, biology) or similarYou have 1 year’s experience in a similar position in a CRO or a pharmaceutical companyYou speak fluent Spanish and EnglishYou are attention to detail and meticulousnessYou have excellent communication skills with different internal and external stakeholdersYou have planning skills and organized work habitsYou have ability to work as part of a teamYou have ability to work on multiple projects simultaneously, manage priorities and work under pressureWhat We OfferIt 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.Benefits PackageContract of Employment: Permanent position.Location: Sant Cugat del Vallès.Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]www.Grifols.Com#J-18808-Ljbffr
📌 Clinical Drug Safety Officer (Madrid)
🏢 Grifols
📍 Madrid