The Global PV Clinical Operations team member is primarily responsible to ensure case processing for safety information received from pre-authorization studies (clinical trials) is conducted in accordance with world-wide regulatory requirements, industry best practices and Teva internal processes and procedures
The Global PV Clinical Operations Team member contributes and supports operational aspects of pre authorization studies for all Teva products worldwide in Teva, aiming to align, simplify, streamline and optimize these processes, as we'll as risk mitigation of gaps, to ensure regulatory compliance in an operationally excellent way.
The Global PV Clinical Operations Team member is responsible to ensure Teva s compliance and laws and regulations to fulfil regulatory compliance and inspection readiness with regards to pre- authorization studies management at Teva.
How you'll spend your day
To be familiar with industry standards and make sure the team operational activities are in full compliance with company policies and SOPs through procedural updates and / or training.
To take part in building the strategy for Pre-authorization Studies (end to end) worldwide, both inter/intra PV and to define and execute the Teva standards from global to regional-local and partner.
Performs medical evaluation and clarifications of clinical trial related adverse events (AE) including narrative content, queries, coding, expectedness, seriousness, causality with company summary/Medical assessment evaluation as applicable.
Act as a consultant or SPOC for various case related activities and maintain knowledge repository of the process updates and changes on real time.
Provide aggregate review of safety information including clinical data to maintain oversight of TEVAs medicinal products safety profile.
Assist in V-Safe related administrative and procedural activities as required or requested and to ensure that all assigned tasks are performed in compliance in accordance to the work instructions and GVP modules.
Ensure that quality data is analyzed for any trending and to prepare team for process stabilization.
Ensure regulatory compliance by following internal reporting key performance indicators for the unit are met.
Your experience and qualifications
Graduation / Post graduation in registered life sciences.
Minimum of 5-6 years of Pharmacovigilance experience in a Biopharmaceutical/CRO industry, including a large international organization
Experience with pre-marketing studies and clinical trial case processing is considered an asset..
In-depth knowledge of international PV regulations
