At Johnson & Johnson,we believe health is everything.
Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https : / / Job Function : Product Safety Job Sub Function : Pharmacovigilance Job Category : Scientific / Technology All Job Posting Locations : Milano, Italy Job Description : 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. Learn more at https : / / / innovative-medicine We are searching for the best talent for an Experienced Specialist Local Medical Safety to be in Milan. 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 Providing insights into ICSR inbound and outbound compliance metrics, perform ICSR reconciliations and leading actions as needed.
Acting as a CAPA content owner and subject matter authority, owning actions as required.
Performing or coordinating procedural document review and improvement, conducting impact assessments as required on local level and support implementation of Global PV relevant documents as applicable. 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 Marketing Authorization Holder (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 Establishing product knowledge with focus on safety profiles, and Therapeutic Area and Disease Pathway knowledge to support the needs of the local Medical and Marketing organization in collaboration with Global Medical Safety (GMS). Acting as local safety expert in cross-functional team meetings and performing training on safety relevant aspects, as appropriate.
Participating in discussion and evaluation of topics related to benefit risk and product safety when requested, and have involvement in local safety signal detection, if applicable. Qualifications / Requirements : Essential Knowledge & Skills
* Scientific / life-science background, medicinal knowledge preferred; proficiency in Medical terminology.
* Ability to balance multiple critical issues.
* Computer literate with basic knowledge of GMS database systems.
* Awareness of and familiarity with industry principles of drug development and pharmacology.
* Proficiency in global and local SOPs.
* Good verbal and written communication skill
* Negotiation and communication skills to work well with partners.
* Ability to establish and maintain open relationships within the organisation and with authorities.
* Validated knowledge of local PV requirements and of global aspects of drug safety. Experience
* Scientific study and experience in pharmaceutical regulations and R&D processes.
* 2-4 years Pharmaceutical industry experience including PV experience would be preferable
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