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Lead PV Professional, Process Excellence (Temporary)

Date: Sep 17, 2022

Location: Bucharest, RO, 050726

Company: Teva Pharmaceuticals

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!

Lead PV Professional, Process Excellence (Temporary)

 

Reports to:  Head of Process Excellence, Patient Safety Operations (Pharmacovigilance)

 

Purpose

 

The Lead PV Professional, part of Process Excellence is responsible for active contribution to all PSO processes and compliance excellence topics, such as: PSO Audits & Inspections management, Training of PSO section members and LSOs/PV functions on PSO process related changes, gap assessments, knowledge management, PSO change control management, coordination of PSO related risk cards and remediation plans, coordination of PSO related deviations and CAPAs.  one-Teva operational business related continuous improvement projects such as PV;TGO (Quality) in relation to PV/patient safety process excellence aspects and other special projects, end-to-end, for all Teva products worldwide. 

The role will be located in Romania.
 


Main responsibilities

 

• Direct and continuous contribution towards ensuring Teva’s compliance with laws and regulations to fulfil regulatory compliance and inspection readiness concerning all aspects of Patient Safety Operations. 
• Acts as individual contributor, by instilling the global PV vision and strategy for PSO process excellence and its regulatory compliance in all sub-areas of responsibility and corresponding projects. 
• Take part to continuous improvement activities, including efficiency, quality and compliance. 
• Part of a team with direct and shared responsibilities around the following: Inspection/audit readiness coordination for PSO; Technical coordinators of PSO related written procedures; Change control management for handling of process changes; Gap assessments; PSO training responsibilities for PSO functions +LSOs/regions; Knowledge management coordination ; All PSO deviation and CAPA writing coordination 
• Oversee and co-ordinate on boarding and training of new PSO colleagues; Coach, develop and mentor employees. Fully accountable for the competency and development of employees within the section.
• In collaboration with other business units, define and achieve annual goals, objectives and KPIs.
• Evaluate the effectiveness of PSO compliance and inspection readiness, and contribute to the plan, design and execute changes/innovations for greatest success in alignment with the Global operating model.
• Contribution to the establishment of new and strengthened synergies with interfacing functions; driving the strategy and proactively championing for interface engagement and optimal ways of working.


Qualifications 

 

• Minimum Master's degree in Life Sciences or another related field (such as: Pharmacy, paramedical studies).
• Minimum of 3 years of Biopharmaceutical/CRO industry experience, including a large international organization.
• In-depth knowledge of international PV regulations.
• Fluent in English, written and spoken.
• Experience in handling Health Authority Inspections and third party audits is an advantage.
• Experience in procedural documentation creation and maintenance is an advantage. 
• Excellent presentation and communication skills (preferably experienced in working with multiple interfaces), attention to detail, strong interpersonal and people skills. 
• Ability to work collaboratively and effectively in a global team environment.

 

If this sounds like the right opportunity for you, send us your CV in English.

 

Please, kindly note that only shortlisted applicants will be contacted.  All personal data is protected by law and will be treated in confidence.

Function

Regulatory Affairs

Sub Function

Pharmacovigilance

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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.