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 Senior Manager, Medical Pharmacovigilance like you. **Mission** The Senior Manager, Medical Pharmacovigilance, provides operational leadership and support for global pharmacovigilance activities for Grifols investigational and marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meets global regulatory reporting timelines. Responsible for coordination of reports, data reviews, medical assessments and overall management of a globally integrated team. **What your responsibilities will be** + Provide oversight and leadership direction to the employees for managing safety data collection, review, analysis and, processing, evaluation from a medical point of view + Coordinates the day-today departmental operations regarding adverse events (AEs), supervise daily reviews all Aes to ensure the cases are appropriately identified and evaluated and provides medical guidance and direction to pharmacovigilance staff (US and Europe) regarding case processing. Ensures compliance with regulatory submission timelines for individual case reports. + Subject matter expert for case processing for both post marketing and clinical trials and other pharmacovigilance activities ensuring continued regulatory compliance and medical evaluation. + Responsible for life-cycle management of pharmacovigilance SOPs and departmental training matrices ensuring compliance of pharmacovigilance personnel giving his/her medical expertise + To ensure, coordinate and manage the global pharmacovigilance processes related to different reports and request to regulatory authorities + Responsible for the process of giving proper answer to Health Authorities involving revision of new documents or renewals of documents such as summary of Product Characteristics, Package Inserts, Product Monographies or clinical overviews and ensures document filling and adequate, archiving. + Responsible for medical reviewing aggregate safety documents such as, but not limited to, Periodic Safety Update Reports, Annual Safety Reports, Risk Management Plans or Development Safety Update Reports. + Monitors changes in global pharmacovigilance regulations and implements necessary changes to ensure global regulatory compliance from a medical point of view. Subject matter expert for regulatory pharmacovigilance audits and inspections. + Project lead on the integration and establishment of the Grifols Pharmacovigilance system + Provide oversight and leadership to the employees for managing safety data review in clinical projects from a medical point of view + Responsible for planning, directing and overseeing clinical safety activities inside the pharmacovigilance responsibility to ensure the global regulatory timelines are met. + Responsible for the processes involving the review, and distribution of serious adverse event information regarding clinical trials and studies of products for which Grifols is responsible. + Provides medical oversight and pharmacovigilance management for all ongoing clinical trials. Reviewing protocol, inform consent forms, Clinical Safety Report, Investigator Brochures and other ad hoc clinical reports. + Responsible for the process involving development safety reports for ongoing clinical trial and ensures compliance with regulatory submission timelines. + Supervision, management and development of global pharmacovigilance team members located in different Grifols sites + Responsible for working with Human Resources staff to select, interview and hire new and employ employees. + Empower employees to take responsibility for their jobs and goals. Evaluate employees to determine compliance with company standards and work performance. + Communicate organization information through department meetings, one-on-one meetings and appropriate email and regular interpersonal communication. **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). + University degree in Biology, Biomedicine, Biochemistry, Biotechnology, Pharmacy or Medicine. + At least 6 years of experience in the pharmaceutical company or CRO + Advanced communication and relation building skills + Advanced English and Spanish language skills (spoken and written) **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 Senior Manager, Medical Pharmacovigilance 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:** Permanent position **Flexibility for U Program:** 2 days remote working **Location: Sant Cugat del Vallès.** www.grifols.com \#LI-Hybrid **\#LI-ER1** Learn more about Grifols (http://www.grifols.com/es/web/international/home) **Req ID:** 522747 **Type:** Indefinido tiempo completo **Job Category:** I + D