Local Medical Safety Specialist, Hungary

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information. LOCAL MEDICAL SAFETY SPECIALIST Location: Budapest, Hungary Contract: full time, permanent Local Medical Safety Specialist is closely cooperating with Local Safety Officer to ensure all pharmacovigilance requirements are met in the best quality and deadlines are strictly kept. In this role, you will also be working closely with other pharmacovigilance teams in the CEE region. The responsibilities & the impact YOU will have: Supporting the Local Safety Officer (LSO) in pharmacovigilance activities Ensuring that the Local Operating Company (LOC) Pharmacovigilance (PV) activities are managed in compliance with local regulations and company policies/ procedures at a local, regional and global level and in accordance with any PV agreements with third party business partners. Having an appropriate safety system of PV and Risk Management in place, in order to assure appropriate safety oversight for products within its responsibility. Managing the safety profile of the products of its responsibility at LOC level. Manage AE/PQC trainings to distributors/vendors and translation of AE/PQC material, where needed.; Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate; Provide and/ or review quarterly listings for the PSMF Annex B (vendor agreements and commercial agreements) for agreements signed by LOC and ensure accuracy and timelines Act as CAPA Content owner and subject matter expert, own actions as required - depending on topic Collaborate with local/cluster case management team to ensure Local Operating Company/ Local Safety Unit audit and inspection readiness Establish adequate collaboration with Case management organization to maintain local compliance oversight on case processing, follow up requests, reconciliation, submission and local literature search Collaborate with LSO to ensure that day-to-day Pharmacovigilance activities and safety activities for non-medicinal products (i.e. cosmetics, medical devices, commodities, nutritional’s) are performed satisfactorily, and that full regulatory compliance is maintained at Local Operating Company level including adequate record management Collaborate with the local Marketing Authorization Holder (MAH) to enable fulfilment of its regulatory responsibilities (including Pharmacovigilance Agreements (PVAs)) and meet their business objectives Qualifications We would love to hear from YOU, if you have: Medical or pharmaceutical sciences background with proven expertise and experience in pharmaceutical regulations and R&D processes is preferred (not a must). Minimum of 2 + years pharmaceutical industry experience with at least 1 year in a PV responsibility role. Degree qualified ideally in Health Sciences. Proven ability to organize workflow activities and manage multiple critical issues. Knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field. Awareness of pharmacovigilance, drug development and pharmacology. Expert knowledge of Global, Regional and Local Pharmacovigilance Procedural Documents as applicable. Computer literate with knowledge of relevant IT safety systems. Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external stakeholders. Ability to establish and maintain open relationships within the organization and with authorities. Demonstrable knowledge of all local pharmacovigilance requirements and of global aspects of drug safety. Fluency in Hungarian and English language is required This is what awaits YOU at J&J: An opportunity to be part of a global market leader. A dynamic and inspiring working environment. Many opportunities to work on challenging projects and assignments. Possibilities for further personal as well as professional development. Many employee benefits. For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we in Johnson & Johnson are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Primary Location Hungary-Budapest-Budapest- Organization Janssen-Cilag Kft. (8396) Job Function R&D Requisition ID 2206008205W