Junior
Clinical Drug Safety Officer - Temporary
Clinical Drug Safety Officer
Ubicación: Sant Cugat del Valles, ES
Tipo de Contrato: Temporal tiempo completo
Número de solicitud de puesto: 548074
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
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Participate in the safety data collection, review, processing, evaluation, analysis and compilation
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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
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Provide technical oversight and be the pharmacovigilance representative for clinical studies
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Subject Matter Expert for documents pertaining to clinical studies
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Contribute to ensure compliance of pharmacovigilance activities with concerned departments such as clinical team or business partners
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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
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Contribute to the assessment benefit/risk of medicines based in the highest quality data management
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Prepare Development Safety Reports (DSURs), and participate in the preparation of Periodic Update Reports (PSURs) and Risk Management Plans (RMPs)
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Create and/or update pharmacovigilance procedures and working practices
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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).
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You have a Bachelor’s Degree in health sciences (pharmacy, nursing, medicine, veterinary) or bioscience (biochemistry, biotechnology, biology) or similar
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You have 1 year’s experience in a similar position in a CRO or a pharmaceutical company
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You speak fluent Spanish and English
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You are attention to detail and meticulousness
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You have excellent communication skills with different internal and external stakeholders
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You have planning skills and organized work habits
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You have ability to work as part of a team
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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. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!
We look forward to receiving your application!
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).
Benefits package
Contract of Employment: Temporary position
Location: Sant Cugat del Vallès.
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Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]
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