The Global PV Clinical Operations team member ensures the processing of safety information from pre-authorization studies (clinical trials) meets global regulatory requirements, industry best practices, and Teva’s internal processes. This role supports operational aspects of pre-authorization studies for all Teva products worldwide, aiming to streamline and optimize processes while mitigating risks to ensure regulatory compliance.
How You’ll Spend Your Day
- Compliance: Ensure team activities comply with industry standards, company policies, and SOPs through procedural updates and training.
- Strategy Development: Participate in building strategies for global pre-authorization studies and define and execute Teva standards.
- Medical Evaluation: Perform medical evaluations and clarifications of clinical trial-related adverse events (AE) including narrative content, queries, coding, expectedness, seriousness, and causality with company summary/medical assessment as applicable.
- Consultation: Act as a consultant or Single Point of Contact (SPOC) for case-related activities, maintaining a knowledge repository of process updates and changes in real-time.
- Safety Review: Provide aggregate reviews of safety information, including clinical data, to maintain oversight of Teva’s medicinal products’ safety profile.
- Administrative Support: Assist in V-Safe related administrative and procedural activities, ensuring all tasks are performed in compliance with work instructions and GVP modules.
- Data Analysis: Ensure quality data analysis for trending and prepare the team for process stabilization.
- Regulatory Compliance: Follow internal reporting key performance indicators to ensure regulatory compliance.
Your Experience and Qualifications
- Education: Graduation/Post-graduation in registered life sciences.
- Experience: Minimum of 5-6 years in Pharmacovigilance in a Biopharmaceutical/CRO industry, including experience in a large international organization.
- Special Skills: Experience with pre-marketing studies and clinical trial case processing is an asset. In-depth knowledge of international PV regulations.