Processing serious & non-serious adverse events from various post-marketing sources Ensure accurate and consistent medical coding through MedDRA (Medical Dictionary for Regulatory Activities) for all events in Safety Database
Data verification between source documents and entered data in Safety Database for evaluation of events/suspect drug coding, seriousness, causality, listedness and narrative writing. Evaluate the need for follow-ups, queries with various stakeholders for correct and accurate data transfer to various parties. Ensure that quality data is analyzed for any trending and to prepare team for process stabilization.
Providing administrative support by taking up complete responsibility of assigned case processing related activities on day-to-day basis.
Coordinate with internal / external stakeholders to obtain necessary information-required for day-to- day operations and to update the reporting manager on status reports on real time basis. Effective communications to be maintained with internal (related departments and units) & external (partners, authorities, vendors) stake holders in order to run the process as transparent as possible.
Qualifications
B.pharm / M.pharm in registered life sciences.
0 to 1 Years of experience in ICSR case processing.
Extensive knowledge of medical terminology, clinical pharmacology, patent treatment, diagnostic investigations ang pathology
Sound knowledge of pharmacovigilance principles and international regulatory requirements related to drug and patient safety
Basic knowledge on TEVA product portfolio, their therapeutic areas expertise, mechanism of actions and its product/patient safety index.
Possess excellent communication skills with professional English speaking, writing, presenting skills and . must be detail oriented
