Overview
Product Safety – Pharmacovigilance focused role based in Milano, Italy. We are searching for the best talent for an Experienced Specialist Local Medical Safety to be in Milan.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Responsibilities
* Purpose: We ensure that the local Pharmacovigilance (PV) system is handled in compliance with local regulations and company policies / procedures at local, regional, and global levels and in accordance with any PV agreements with third party business partners. We support activities related to the pharmacovigilance regulatory requirements of Marketing Authorization Holders (MAH) and / or study sponsors, as applicable.
* You will: Ensure the management of the local Pharmacovigilance (PV) system as described and in accordance with any PV agreements with third party business partners. Ensure pro-active Benefit Risk Management throughout product life cycle by translating global safety data to insights and actions, and tailoring to local specificities and needs. Conducting local benefit-risk activities to ensure pro-active benefit-risk management.
* Icsrs\'s management and oversight: Ensuring local collection, review, reporting, reconciliation, and follow up of Individual Case Safety Reports (ICSR) and implementation of the local literature process. Maintain active involvement in day-to-day ICSR management related activities and maintain oversight of corresponding vendor activities as required.
* Aggregate reports: Leading Preparation, review, tracking and timely submission of aggregate reports to all relevant local authorities or other official bodies, where applicable.
* Local Safety compliance: Responsible for timely provision of high quality and accurate contributions to PSMF, as for policy. Ensure LOC and LSU audit and inspection readiness.
* Safety regulations: Ensure awareness and participate in the review of new / revised safety regulations, evaluating impact on local / global processes and notifying appropriate global and regional groups of changes as appropriate. Actioning implementation of new legislation with local impact for LMS-owned activities. Maintain focused engagement in local industry associations and drive local policy shaping initiatives based on One J&J Voice.
* Pharmacovigilance service provision: Ensure that day-to-day PV activities and safety activities for medicinal and non-medicinal products (i.e., medical devices) are performed satisfactorily. Collaborating with the local MAH to enable fulfilment of its regulatory responsibilities and meet their business objectives. Provide timely and accurate EU Pharmacovigilance System Master File (PSMF) contributions and ensure adequate process is established for the implementation and the maintenance of the local “PSMF”, as applicable. Connect with the HA, when applicable, to clarify requirements in support of LMS-wide policy, process harmonization / improvement. Ensure business continuity to safeguard compliance. Provide support to the Related Research Activities Center of Excellence (RRA CoE) for local Related Research Activities (RRA). Collaborate with project owners and LMS operations to provide input for the reporting process of potential AEs included in local data generating activities to ensure appropriate safety monitoring.
* PV contract management: Leading pharmacovigilance agreement (PVA) reviews, assisting with handling local PVAs, and ensuring local oversight and implementation, including local safety unit (LSU) training and adherence to PVAs. Coordinating the provision of support for third party safety agreements locally e.g. local Vendor Agreements, collaborating closely with central functions, and providing ongoing oversight to ensure safety obligations are met. Providing and / or reviewing listings for the pharmacovigilance system master file (PSMF) for agreements signed by the LOC ensuring precision and timeliness.
* Local Communications: Ensure accurate handling of Health Authority (HA) safety related queries (communication, response, and escalation). Working with Regulatory Affairs to forward any safety-related inquiry or relevant communication to the appropriate regional and global groups as appropriate. Supporting the Qualified Person to provide safety-related regulatory communications where required.
* PV-Safety training support: Performing training for LOC employees covering Pharmacovigilance, safety aspects of products, and handling AE / PQC trainings to distributors and vendors.
* Benefit Risk Management: Establish the processes and activities to maintain pro-active benefit risk management throughout the product life cycle.
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