Lead PV Professional, ICSR Quality

2 weeks ago

Bengaluru, India Teva Pharmaceuticals Full time

The opportunity

The Lead 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 Quality Standards and Oversight (Global, Regional, Local and Partner), end-to-end, for all Teva products worldwide.

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.

Your experience and qualifications

M.Pham 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.

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.

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