04 September 2015 (Rome, Italy) - PM Clinical today announced the appointment of Stefania De Santis to the role of Director of Pharmacovigilance to join its growing business line of pharmacovigilance applications, services and consultancy.
Stefania is responsible for strategic planning and workflow development within the pharmacovigilance department as well as quality assured delivery of pharmacovigilance services.
She is also qualified as EU QPPV.
Stefania brings almost 30 years of experience in the pharmaceutical industry to her new role with PM Clinical. She has been involved in various departments throughout her career, but since 1992 she has been dedicated to the field of pharmacovigilance in the role of Head of Corporate Drug Safety and qualified Deputy EU QPPV for a major pharmaceutical company. Stefania has extensive experience in all aspects of pharmacovigilance operations, in both pre-registration and post-marketing settings, and her areas of expertise include case processing, PSUR and DSUR preparation, ICSR/SUSAR electronic transmission to the EMA, safety database validation, safety variations, RMPs development, SDEA/Safety Management Plans and liaising with regulatory authorities. She is certified by the EMA for the use of Eudravigilance and EXVMPD (Medicinal Product Dictionary).
Daniela Marcozzi, VP of Pharmacovigilance Services, said, “I am pleased to announce the appointment of Stefania to our pharmacovigilance team. Not only is she an expert on the various aspects of pharmacovigilance operations and safety systems, she is also a qualified EU QPPV and can step into this role when needed. Stefania is no doubt going to be a valuable asset to our pharmacovigilance team and to any client needing support with safety systems, case processing, quality assurance and compliance within the pharmacovigilance team”.
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About PM Clinical
PM Clinical is an international Clinical Research Organization (CRO) providing expert and innovative clinical, regulatory, pharmacovigilance and quality assurance solutions to drive the development of products and devices to market in a timely and cost-effective manner. We provide product development and regulatory consultancy, clinical project management and monitoring services for pre-clinical through the whole product development program and post-market product life cycle as well as offer a full package of clinical consultancy, biometrics and pharmacovigilance services and safety systems. PM Clinical completes its portfolio by helping companies operating in the drug and device development sector with quality and compliance solutions to meet regulatory requirements.