Teva Jobs

Pharmacovigilance Professional

Date: Jun 20, 2024

Location:

Bucharest, Romania, 050713

Company: Teva Pharmaceuticals

Job Id: 56065

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

We are looking for a new colleague on a temporary role (2 years) Pharmacovigilance Professional in Bucarest.

The Pharmacovigilance professional 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.

The Pharmacovigilance professional 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 quality Standards and Oversight (Global-Regional-Local-Partner) 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 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.

• In conjunction with the necessary interfaces; procure, develop, oversee and maintain a Global System for governance of ICSR quality standards and oversight worldwide.

• Assess requirements for ICSR Quality standards and oversight resources, equipment and systems to maximize efficiency.

• Work in collaboration with Systems and Innovation group to develop quality reports. Produce, analyze and execute reports from QlikSense, COGNOS or any other report generation system.

• Interface activities with QPPV office and Compliance i.e. Agreements (Third party alliance; Agreements Team for ICSR exchange methodology/timelines) and Compliance standards.

• Support with onboarding and ongoing training aspects needed within the Quality standards and oversight team.

• Governance of (i) Validation rules (ii) Distribution rules (iii) licensing partner and service provider agreement PV templates defining timelines and methodology for case reporting in advance of contract negotiation (iv) PPD and MedDRA governance (v) case processing conventions (vi) Reconciliation.

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.

• Project Management experience is an advantage.

• Fluent in English.

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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.

EOE including disability/veteran