PV scientist, Senior Specialist

Job Description

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.The purpose of this role is to support the GPS safety strategy leads in order to provide integrated medical safety strategies for the assigned investigational and core (high-risk) marketed products. This includes input into safety aspects of clinical development, risk management and benefit-risk management for assigned products.Key responsibilities of the Pharmacovigilance Scientist Expert Level 2 within Safety Science include (but not limited to):Signal detection and management:o Reviewing reports and data in dedicated tools (e.g. Spotfire, EVDAS, Empirica Signals, as applicable) for signal detection purposes o Reviewing and assessing clinical and safety database outputs; medically/scientifically analyzing and interpreting aggregate safety data from clinical trials and post-marketing sources o Reviewing the scientific literature (non-ICSR literature) for safety surveillance and signal detection purposeso Supporting the analysis of safety signals (including contributions to the signal evaluation report, and BRAT, PVAB, MSEB and LDB meeting contributions) o Emerging Safety Issue Reports: supporting the communication to external stakeholdersBenefit/Risk Activities:o Supporting the definition of the safety profile including the definition of important risks/safety concerns o Supporting the delivery of content related input into the core benefit-risk document and associated documents(d)RMP (updates) and periodic safety reports o Supporting the delivery of content related input into (d)RMPs o Support the local adaption of RMPs o Supporting the delivery content related input into periodic safety reports Submissions and Safety Variations o Providing contributions to ISS/SCS IAP, HA briefing documents, Modules 2.7.4 and 2.5, RMP and product informationo Providing content related safety input into Clinical Overview AddendumClinical trial activities o Supporting the delivery of content related input into the safety sections of the IMPD, IB and ICFo Supporting the delivery of safety related input into the development of other clinical trial related documents such as clinical trial protocols, integrated analysis plan, clinical trial reportso Providing safety related input for data monitoring committees (i.e. charters, meeting minutes) Other activities o Providing responses to queries from auditors/inspectors and participate in interviewso Contributing to the implementation of post-authorization safety studieso Developing and maintaining MedDRA CMQs for the analysis of potential signals and aggregate safety datao Developing product-specific trainings for internal or external stakeholders o Providing expert input into the standardization and improvement of processes within GPS and GDWhat we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!Curious Apply and find more information at https://jobs.vibrantm.com ,

Keyskills :
active directorytroubleshootingenvironmentwindowsslarisk managementclinical trialsdata monitoringtherapeutic areasclinical developmentpersonal development