PVpharm
Inés Bartolomé Sanza currently works as a Pharmacovigilance Officer at PVpharm, where Inés serves as a Project Manager in the PVCS department. In this role, Inés coordinates PV activities for national and international clients, reviews literature screening search results, manages case submissions to Competent Authorities, and communicates with local NCAs. In the past, Inés has gained experience as a Fisioterapeuta at various companies before pursuing a Master's degree in the pharmaceutical industry. Through their education and diverse work experience, Inés has developed a strong foundation in pharmacovigilance and regulatory affairs.
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PVpharm
www.pvpharm.com https://www.pvpharm.com/careers -PVpharm provides consultancy services in Pharmacovigilance for the Pharmaceutical Industry -We work independently or in collaboration with other PV service providers / CRO's -EU QPPV service -Local QPPV services for Spain -Training pharmacovigilance and GVP -Pharmacovigilance GVP Audits -EudraVigilance EVWeb and the XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary). Possibility internal certified on-site training for pharmaceutical companies. -Registration with Eudravigilance for Pharmaceutical companies. -Introduction of information of medicinal products in the XEVMPD. -Development of IDMP implementation consultancy services. -Case management of suspected adverse reactions, including contact with reporters, MedDRA coding, Data Entry and Electronic reporting to health authorities. -Literature searches for Pharmacovigilance. -Implementation of the company's Pharmacovigilance system, including Standard Operating Procedures for Pharmacovigilance (SOPs / PNTs). -Development and revision of Pharmacovigilance documents, including Periodic Safety Update Reports (PSURs), Risk management plans (RMPs) and Elaboration of the Pharmacovigilance System Master File. JOBS: please visit our website at www.pvpharm.com