The opportunity
We are looking for a new colleague on a temporary role (2 years) Pharmacovigilance Professional in Bucarest.
The Pharmacovigilance professional is a main contributor to ensure Teva’s compliance with laws and regulations to fulfil regulatory compliance and inspection readiness with regards to all ICSR Quality Standards and Oversight (Global, Regional, Local and Partner), end-to-end, for all Teva products worldwide.
The Pharmacovigilance professional is a main contributor to foster and strengthen 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 quality Standards and Oversight (Global-Regional-Local-Partner) to ensure optimal oversight and governance.
How you’ll spend your day
• To devise, execute and manage projects in accordance with defined timings and deliverables, to ensure Teva’s full oversight and governance of ICSR Quality standards and oversight.
• To ensure individual's compliance with all laws and Regulations as well as internal policies and procedures defined and KPIs related to all ICSR quality standards and oversight aspects.
• To contribute/support the generation and maintenance of Standard Operating Procedures (SOPs) and Working Instructions (WIs) to ensure optimal operational handling of ICSR Quality standards and oversight.
• To act (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.
• To support the development of an ever efficient operational business process and systems for handling of Teva ICSR Quality standards and oversight.
• To establish (on request/as assigned) a strong interface and to define/execute 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.
• To support any Global led guidance to world-wide LSOs wrt local ICSR processes and to foster greater collaboration through Working Groups, LSO Forums and other opportunities.
• To manage and oversee the development of suitable operational guidances and templates for LSOs-Regions-Global-Partners to facilitate appropriate and ever-efficient ICSR quality standards and oversight handling in Teva.
• Evaluate the effectiveness of ICSR Quality standards and oversight structures and processes, and plan, design and execute changes/innovations for greatest success in alignment with the Global operating model.
• Develop and enhance ICSR Quality standards and oversight handling capabilities and expertise for the future.
• In conjunction with the necessary interfaces; procure, develop, oversee and maintain a Global System for governance of ICSR quality standards and oversight worldwide.
• Assess requirements for ICSR Quality standards and oversight resources, equipment and systems to maximize efficiency.
• Work in collaboration with Systems and Innovation group to develop quality reports. Produce, analyze and execute reports from QlikSense, COGNOS or any other report generation system.
• Interface activities with QPPV office and Compliance i.e. Agreements (Third party alliance; Agreements Team for ICSR exchange methodology/timelines) and Compliance standards.
• Support with onboarding and ongoing training aspects needed within the Quality standards and oversight team.
• Governance of (i) Validation rules (ii) Distribution rules (iii) licensing partner and service provider agreement PV templates defining timelines and methodology for case reporting in advance of contract negotiation (iv) PPD and MedDRA governance (v) case processing conventions (vi) Reconciliation.
