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 that foster an inclusive environment.** Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma-derived medicines with presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a Clinical Safety Specialist like you. The personnel who cover the workplace will develop his/her activities within the pharmacovigilance system Master File (PSMF), Standard Operating Procedures (SOPs) and Working Practices (WPs) of the company and following the Pharmacovigilance and clinical trials legislation, handling the adverse drug reactions associated to the drugs manufactured by Grifols and under an investigational plan. **What your responsibilities will be** + Participation in the processes of involving the collection, processing, review and distribution of adverse event information regarding development Grifols pharmaceutical products. Ensures compliance with regulatory submission timelines for individual case reports. + Responsible of technical oversight and pharmacovigilance management for all ongoing clinical and post marketing studies. + Includes but not limited to develop the safety management plan, provides PV training for appropriate parties, reconciliation of AE data, participates in on-going clinical studies´ reviews and develop and design the SAE form. + Responsible for life-cycle management of clinical pharmacovigilance SOPs and working practices + Responsible and monitors changes in global pharmacovigilance regulations and implements necessary changes to ensure global regulatory compliance from a clinical view. + Responsible of the data reconciliation regarding safety with other teams such as clinical team, CROs and third parties. + Compliance with archiving tasks for deliverables and important documents related to clinical studies + Manages risk management plans and ensures document filing and archiving. + Contributes and/or manages DSURs and PSURs ensuring document filing and archiving. + Gives support to respond requests from regulatory agencies **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 accommodations may be made to enable individuals with disabilities to perform the essential functions). + A bachelor’s degree, in health sciences, pharmacy, biology, biotechnology, or similar. + 3 years of experience in pharmacovigilance. High desirable in clinical safety events. + Ability to adapt to change. + Teamwork. + Analytical and synthesis skills. + Details oriented + Advanced English. **What we offer** It’s a brilliant opportunity for someone with the right talents. Grifols understands you want a challenging and rewarding career in a critical function Clinical Safety Specialist help you grow professionally. Information about Grifols is available at www.grifols.com. If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply. We look forward to receiving your application. Grifols is an equal opportunity employer. **Flexible schedule:** Monday-Thursday 7-10 to 16-19h and Friday 8-15h. **Benefits package** **Contract of Employment:** Temporary position **Flexibility for U Program:** 2 days remote working **\#LI-ER1** \#LI-Hybrid Learn more about Grifols (http://www.grifols.com/es/web/international/home) **Req ID:** 523793 **Type:** Temporal tiempo completo **Job Category:** I + D