Job Description

Who are we?

Teva is a global pharmaceutical leader and the world\'s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world\'s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we\'ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!



Responsible for operational overview of ICSRs (pre and post marketing) and its related activities globally and support LSO to have local regulatory requirements in alignment with global standards for all Teva products

Support Sr. SME to develop, execute and lead the Global PV vision and strategy for PSO ICSR Management.

Responsible for the generation and maintenance of Standard Operating Procedures (SOPs) and Working Instructions (WIs) to ensure optimal operational handling of ICSR and its related activities.

Responsible for the PSO ICSR Management Operations report to provide overview of volumes, turnaround times, compliance, quality, cost and efficiencies.

Bring simplification with innovative methodologies e.g. BOTs, Machine learning etc. to better leverage capabilities and capacities for ICSR handling and its related activities.

Lead and drive the internal operational meetings per the governance structure and contractual arrangements with various stakeholders/vendors.

Provide, advise and guide ICSR management team on the best practice case management aspects.

To ensure a strong interface with PSO functions Organized Data, PV Governance team, ICSR Quality KPIs & Metrics and Process Excellence teams. 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) for an efficient oversight of operations.

Coach develop and mentor employees to achieve their full potential accountable for the competency and development of employees within the team.

To have a complete oversight and efficient management of CAPA/deviations for ICSR management ensuring timely closure with appropriate measures.

To strategize and execute actions to ensure KPIs and metrics for the teams with respect to quality and compliance are met that are aligned to industry standards

Qualifications

Minimum Master\'s degree in Life Sciences/Pharmacy or another related field.

Minimum of 12 years of Biopharmaceutical/CRO industry experience in pharmacovigilance and 5 years of people management, including a large international organization.

6-Sigma black belt or recognized project management qualification/accreditation.

Knowledge and understanding of relevant GxP requirements applicable for position

Experience of regulatory authority inspections

Sound knowledge of pharmacovigilance principles and international regulatory requirements related todrug and patient safety.

Basic knowledge on TEVA product portfolio, their therapeutic areas expertise, mechanism of actions and its product/patient safety index.

Fluent in English.

Function

Regulatory Affairs

Sub Function

Pharmacovigilance

Already Working @TEVA?

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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.

Teva Pharmaceuticals