Job Information
Grifols Shared Services North America, Inc Pharmacovigilance Specialist in Sant Cugat del Valles, Spain
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 opportunity fostering an inclusive environment where diversity makes us be 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 Pharmacovigilance Specialist like you.
What your responsibilities will be
You will provide operational support for global pharmacovigilance activities of Grifols marketed products.
You will ensure pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines.
You will be responsible for data review, compilation and analysis including management of the integrated safety database.
You will manage Adverse Events including activities such as processing adverse event case reports and conducts follow-up.
You will notify regulatory agencies and business partners accordingly; responds to requests from regulatory agencies.
You will draft and review periodic safety update reports.
You will participate in the evaluation of Grifols products safety profiles.
You will contribute to ensure compliance of pharmacovigilance activities.
You will take part in self-inspection visits, audits, inspections and in CAPAs management.
You will provide training to concerned persons based on the training plan and managing training documentation.
You will be involved in specific countries local pharmacovigilance activities.
You will provide support in creating and updating the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal business practices or working instructions.
You will serve in an advisory capacity including activities such as product monographs review; draft responses to pharmacovigilance requests from regulatory agencies; participates in the drafting and implementation of pharmacovigilance contracts and agreements. Assist management with ad hoc requests.
Who you are
You have a bachelor’s degree in health sciences (pharmacy, nursing, medicine, veterinary) or bioscience (biochemistry, biotechnology, biology) or similar.
You have at least 2-4 years of pharmacovigilance experience (knowledge of Good pharmacovigilance practices; existing legislation, regulations and guidelines).
You speak fluent Spanish and English.
Desirable French and Chinese.
You have excellent communication skills with different internal and external stakeholders.
You have ability to work on multiple projects simultaneously.
You have planning skills and organized work habits.
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.
Flexible schedule
Benefits package
Contract of Employment: Permanent position
Flexibility for U Program: Hybrid
Location: Sant Cugat del Vallès
www.grifols.com
Learn more about Grifols
Req ID: 526467
Type: Indefinido tiempo completo
Job Category: Farmacovigilancia