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Sr. PV Professional, ICSR Quality

4 months ago

Bangalore, India Teva Pharmaceuticals Full time
Who we are

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 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 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.
  • 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 Master's 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.
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.