Sr. PV Professional, ICSR Quality

3 weeks ago

Bengaluru, Karnataka, India Thepharmadaily Full time
Job Description

- As Sr. 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), the role in the Global Patient Safety & Pharmacovigilance department within Teva Global R&D (Research & Development) reports to Sr. manager, ICSR Quality KPIs, reports & metrics Team Leader.
- The Sr. PV professional, ICSR quality 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 reports, KPIs & Metrics, end-to-end, for all Teva products worldwide.
- The Sr. PV professional, ICSR quality 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 reports, KPIs & Metrics 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 reports, KPIs & Metrics standards.
- To ensure individuals compliance with all laws and Regulations as well as internal policies and procedures defined and KPIs related to all ICSR reports, KPIs & Metrics aspects.
- To contribute/support the generation and maintenance of Standard Operating Procedures (SOPs) and Working Instructions (WIs) to ensure optimal operational handling of ICSR reports, KPIs & Metrics.
- 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 reports, KPIs & Metrics.
- 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.

Your experience and qualifications

- Minimum Masters degree in Life Sciences or another related field.
- Minimum of 3 years of Biopharmaceutical/CRO industry experience, including a large international organization.
- At least 1 year of direct people/project leadership experience.
- Experience in handling Health Authority Inspections.

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