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Pharmacovigilance Associate II
2 weeks ago
The opportunity
- The Global PV Clinical Operations team member ensures case processing for safety information from pre-authorization studies is in line with regulatory requirements, best practices, and Teva internal procedures.
- Contributes to operational aspects of pre-authorization studies for Teva products worldwide, aiming to simplify processes and ensure regulatory compliance.
- Responsible for compliance with laws and regulations related to pre-authorization studies management at Teva.
How you'll spend your day
- Familiarize with industry standards and ensure team activities comply with company policies and SOPs.
- Participate in building strategies for Pre-authorization Studies worldwide and define Teva standards.
- Medical evaluation of clinical trial adverse events and act as a consultant for case-related activities.
- Provide aggregate review of safety information and assist in V-Safe administrative activities.
- Analyze quality data and ensure regulatory compliance.
Your experience and qualifications
- Graduation / Post graduation in life sciences.
- 5-6 years of Pharmacovigilance experience in a Biopharmaceutical/CRO industry.
- Experience with pre-marketing studies and clinical trial case processing.
- In-depth knowledge of international PV regulations.
Teva's Equal Employment Opportunity Commitment
Teva Pharmaceuticals provides equal employment opportunity regardless of age, race, religion, sex, disability, pregnancy, and other legally recognized statuses under applicable laws. We promote a diverse and inclusive workplace. Accommodations can be requested during the recruitment process for a more accessible experience.
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