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Senior PV Professional, ICSR Quality
2 months ago
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
As a Senior PV professional, ICSR quality, part of ICSR Quality KPIs, reports & metrics Team within the ICSR Quality, KPIs & Metrics sub-function within Patient Safety Operations (PSO), you will be part of the Global Patient Safety & Pharmacovigilance department within Teva Global R&D (Research & Development) and report into Senior Manager, ICSR Quality KPIs, reports & metrics Team Leader. As a Senior PV professional, ICSR quality you will be the main contributor to ensure Teva’s compliance with laws and regulations to fulfil regulatory compliance and inspection readiness with regards to all ICSR reports, KPIs & Metrics, end-to-end, for all Teva products worldwide. In this role you will contribute to fostering and strengthening alliances with: PV stakeholders, in particular - QPPV, Compliance (namely Agreements, Compliance standards team), LSOs/Regions, as well as strong partner collaboration (licensing and service provider partners) and to define and maintain an ever efficient set of optimal ICSR reports, KPIs & Metrics to ensure optimal oversight and governance.
How you’ll spend your day
• devising, executing and managing projects in accordance with defined timings and deliverables, to ensure Teva’s full oversight and governance of ICSR reports, KPIs & Metrics standards
• ensuring individual's compliance with all laws and Regulations as well as internal policies and procedures defined and KPIs related to all ICSR reports, KPIs & Metrics aspects
• contributing / supporting the generation and maintenance of Standard Operating Procedures (SOPs) and Working Instructions (WIs) to ensure optimal operational handling of ICSR reports, KPIs & Metrics
• acting (on request/as assigned) as PSO business owner for any systems or tools implemented as part of the Global PSO and S&I (Systems and Innovation) technology driven strategy
• supporting the development of an ever efficient operational business process and systems for handling of Teva ICSR reports, KPIs & Metrics
• establishing (on request/as assigned) a strong interface and defining / executing inter function policies/SOPs with all necessary PV interfacing functions (QPPV, Compliance, LSOs/Regions) as well as strong partner collaboration (licensing and service provider partners) to ensure a full oversight
• supporting any Global led guidance to world-wide LSOs with local ICSR processes and fostering greater collaboration through Working Groups, LSO Forums and other opportunities
• managing and oversee the development of suitable operational guidances and templates to facilitate appropriate and ever-efficient ICSR reports, KPIs, Reports & Metrics handling in Teva
• evaluating the effectiveness of ICSR reports, KPIs & Metrics structures and processes, and plan, design and execute changes/innovations for greatest success in alignment with the Global operating model
• developing and enhancing ICSR reports, KPIs & Metrics handling capabilities and expertise for the future
• in conjunction with the necessary interfaces procuring, developing, overseeing and maintaining a Global System for governance of ICSR reports, KPIs & Metrics worldwide
• assessing requirements for ICSR reports, KPIs & Metrics resources, equipment and systems to maximize efficiency
• working in collaboration with Systems and Innovation group to develop ICSR compliance reports
• producing, analyzing and executing report from QlikSense, COGNOS or any other report generation system
• interfacing activities with QPPV office and Compliance i.e. Agreements (Third party alliance; Agreements Team for ICSR exchange methodology/timelines) and Compliance standards
• supporting with onboarding and ongoing training aspects needed within the reports, KPIs and Metrics team
• Master's degree in Life Sciences or another related field
• Relevant work experience in Biopharmaceutical / CRO industry, including a large international organization is highly preferred
• At least 1 year of people / project leadership experience is preferred
• Experience in handling Health Authority Inspections is a plus
• Project Management experience is an advantage
• Fluent in English
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
