Descripción de la oferta
Candidates with 3+ years of Pharmacovigilance / Safety experience are welcome to apply.Responsibilities:- Responsible for establishing and implementing the pharmacovigilance system for marketing authorization holder (MAH)/sponsor.- Maintaining and improving compliance.- Review and submit pharmacovigilance-related documents, including but not limited to PSUR/PBRER/DSUR.- Ensure the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to authorities.- Maintenance and improvement of the quality system in pharmacovigilance system (oversight over relevant aspects, e.G. SOPs, contractual arrangements, database, compliance and quality of expedited reporting, submission of periodic update reports, audit reports, training and so on).- Ensure a full and prompt response to any request from the authorities for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product.- Provide any other information relevant to the benefit-risk evaluation to the authorities.- Provide input into the preparation of regulatory action in response to emerging safety concerns (e.G. variations, urgent safety restrictions, and communication to patients and healthcare professionals).- Act as a single pharmacovigilance contact point for the authorities.- 24-hour basis and also as a contact point for pharmacovigilance inspections.- Keep the username and password provided by the EMA for the access to the EudraVigilance database under an adequate regime of security measures; access to the EudraVigilance database refers to access using the EVDAS and/or the EVWEB.- Support gateway connection.- Overview of safety profiles and all safety concerns for all authorised products of the MAH.- Awareness of any conditions or obligations adopted as part of the marketing authorisations relating to safety or the safe use of the products.- Awareness of risk minimisation measures.- Draft/review risk management plans.- Conduct a risk management plan agreed by Health Authorisation.- Review and sign-off of protocols of post-authorisation safety studies.- Awareness of post-authorisation safety studies requested by an authority including the results of such studies.- Establishment, development and maintenance of the Pharmacovigilance System Master File (PSMF)Qualifications:- Bachelor degree or above with Medicine, pharmacy, biology, nursing and equivalent major- 3 years of Pharmacovigilance /Safety experience.- Fluent in Spanish and English (Both Written and Spoken)- Proficiency Basic Microsoft Word, PowerPoint, Excel.- Knowledge of relevant guidelines, and regulations is preferred.
