Pharmacovigilance Associate
Zagreb, Croatia, 10000
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 currently looking for a Pharmacovigilance (PV) Associate, acting as Deputy Local Safety Officer, supporting the Head of Pharmacovigilance Switzerland and Local Safety Officer (local QPPV) in maintenance of the local Pharmacovigilance System, in close collaboration with the PV cluster, regional and global Pharmacovigilance Organization of Teva Pharmaceuticals.
How you’ll spend your day
- Managing the collection and processing of Adverse Events/Special Situations in compliance with local and regional regulations and the applicable company SOPs
- Conducting reconciliation of safety data with other departments and partners
- Supporting authority requests, signal screening and signal reporting activities
- Supporting management of local SOPs and procedures, including writing the documents
- Organizing and delivering PV trainings to other departments and other relevant stakeholders as delegated
- Supporting planning submission and tracking of Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR), Risk Management Plans and Company Core Safety Information (CCSI) activities as per local requirements and internal procedures
- Supporting development, updates and tracking of additional Risk Minimization Measures (aRMM) and of PV agreements, as per internal procedures
- Coordination of Health Hazard Assessments
- Representing drug safety and providing relevant inputs in local projects and activities
- CAPA management
- Contributing to PSMF compliance
Your experience and qualifications
- Degree in a life science related field (medical, pharmaceutical, nursing or natural science background)
- Experience of minimum 2 years in Pharmacovigilance is highly preferred
- Good knowledge and understanding of Swiss regulations with regards to pharmacovigilance practices for medicinal products and medical devices will be considered an advantage
- Good knowledge of ICH (GCP) and EU Good Pharmacovigilance Practice (GVP) is a strong advantage
- Basic level of medical knowledge
- A confident handling of Microsoft Office Tools (Excel, Word, PowerPoint) is required
- Fluent in German and English (business level)
- Analytical thinking
- Reliable and team-oriented
- Open for innovation and change
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. 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.