Scope
Act as expert of the risk-benefit balance of medicinal products licensed by both Kedrion and its Subsidiaries, in order to keep it constantly updated, detecting any possible variation and impact and contributing to the safe use of the products.
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Main Responsability:
⦁ Collects and evaluates any safety information to adequately characterize the risk-benefit balance associated with Kedrion&rsquo;s (and its Subsidiaries) medicinal products, to keep it constantly updated and to confirm that it remains favorable as set out by the CAs at the time of granting the MA. ⦁ Manages Aggregate Reports (PSUR/PAER/PBER/AdCO) for the medicinal products belonging to the Kedrion Pharmacovigilance system (it includes products licensed by Kedrion and its Subsidiary) for the parts of pharmacovigilance competence. ⦁ Manages the Risk Management Plans (RMP/RMM) related to those products mentioned above, for the parts of Pharmacovigilance competence.&nbsp; ⦁ Supports the UK/EU QPPV and the PV Safety unit in keeping updated the safety sections of products labeling. ⦁ Supports the UK/EU QPPV and the PV Safety unit in all phases of the signal management process, from their detection to their communication, including the management of the identified actions. ⦁ Supports the UK/EU QPPV and the PV Safety unit in the management of safety changes identified following the detection of new risks and/or new information on already known risks. ⦁ Supports the UK/EU QPPV and the PV Safety unit in defining specifications and pharmacovigilance plans. ⦁ Supports the UK/EU QPPV and the PV Safety unit in in drafting and updating the Reference Safety Information documents.&nbsp; ⦁ Supports the UK/EU QPPV in identifying risk minimization measures aimed at preventing or reducing the number of adverse reactions, or at reducing their severity and impact on patients. ⦁ Monitors the safety information associated with current important risks (both potential and identified) confirmed by the Competent Authorities and listed in the aggregated reports. ⦁ Manages commitments received from the competent authorities following assessments of PSUR, RMP, ACO, registration dossier, labeling. ⦁ Defines and maintains an updated register of important safety concerns and missing information, both identified and potential, and the risk minimization measures associated with them.&nbsp; ⦁ Participates in the definition of specific Follow Up Questionnaires to be sent to reporters of ADR/special situations considered of particular interest. ⦁ Draws up and keeps updated the tables describing the additional and routine PV activities. ⦁ Drafts / reviews SOPs, Working Instructions and Technical Documents. ⦁ Acts as back-up for case processing in Kedrion safety database and Follow-up activities in case of an abrupt suspension of services of the Service Provider ⦁ Monitors the pharmacovigilance activities outsourced to the Service Provider ⦁ Performs the daily screening of the Pharmacovigilance mailbox and forwards the emails containing safety info to the Service Provider ⦁ Manages the exchange of safety information for products for which Kedrion acts as distributor ⦁ Performs periodic safety data reconciliation with other Kedrion&rsquo;s departments
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Requiremets:
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⦁ Degree in a medical-scientific field (Pharmacy, Biology, Chemistry with an organic focus, Pharmaceutical Chemistry and Technology, Medicine, etc.) ⦁ At least 6 months of experience in managing PSUR and/or DSUR and/or RMP and/or AdCO ⦁ Good knowledge of English ⦁ Good knowledge of the Microsoft Office Suite
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Kedrion Biopharma è un’azienda biofarmaceutica italiana che raccoglie e fraziona il plasma con lo scopo di produrre e distribuire in tutto il mondo farmaci plasma-derivati per la prevenzione e il trattamento di patologie e condizioni rare e debilitanti come i Disordini della Coagulazione, i Disturbi Neurologici e le Immunodeficienze Primitive e Secondarie.
Tutte le attività di Kedrion hanno come orizzonte ultimo i pazienti. Per servire al meglio ciascuno di loro, ci impegniamo ogni giorno nella ricerca, nell’innovazione e nel miglioramento continuo di prodotti e processi.

Kedrion Biopharma

Kedrion Biopharma is an Italian biopharmaceutical company specializing in plasma-derived medicines for rare and debilitating diseases. We seek a temporary PHV Specialist with a medical-scientific degree and experience in pharmacovigilance. The candidate will manage risk-benefit evaluations and safety documentation. We offer a supportive, inclusive environment focused on employee well-being and professional growth.

PHV Specialist Risk Evaluation - Temporary

Summary