Medical Manager Pharmacovigilance
Dublin, ES
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¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y medicina transfusional y desarrollamos, producimos y comercializamos medicamentos, soluciones y servicios innovadores en más de 110 países y regiones. |
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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.
Mission
As Medical Pharmacovigilance Manager, you will provide operational leadership and medical oversight for global pharmacovigilance activities related to both investigational and marketed products. Your goal will be to ensure regulatory compliance, timely and high-quality deliverables, and robust safety evaluation throughout the lifecycle of the products.
What your responsibilities will be
- Review, analysis, processing, and evaluation from a medical point of view.
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- Review 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.
- To ensure the global pharmacovigilance processes related different reports and request to regulatory authorities
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- Revision of new documents or renewals of documents such as summary of Product Characteristics, Package Inserts, Product Monographies or clinical overviews and ensures document filing and adequate, archiving.
- Medical reviewer of 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.
- Safety data review in clinical projects from a medical point of view
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- Involvement in clinical safety activities inside the pharmacovigilance responsibility to ensure the global regulatory timelines are met.
- Involvement in 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.
- Provides reconciliation of AE data with different parties of on-going clinical trial through reviews following the safety management plan.
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).
- You have a University Degree in Medicine.
- 3+ years of proven experience in pharmacovigilance within a pharmaceutical company or CRO.
- Deep knowledge of global pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP)
- Understanding of clinical development and safety assessment in trials and post-marketing.
- Strong organizational and communication skills, with the ability to translate complex medical data into clear assessments.
- Proactive, collaborative mindset with the ability to work cross-functionally.
- Advanced level of English
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!
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: Permanent position
Location: Sant Cugat del Vallès or Ireland.
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Ubicación: EMEA : Irlanda : Dublin || EMEA : Irlanda : En Remoto || SPAIN : España : Sant Cugat del Valles:[[cust_building]]