Teva Pharmacovigilance Associate 

India, Karnataka, Bengaluru 

692455358

• Processing serious & non-serious adverse events from various post-marketingsources.
• 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 datatransfer to various parties.
• Ensurethatqualitydataisanalyzedforanytrendingandtoprepareteamforprocessstabilization.
• 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.

• inSafetyDatabaserelatedadministrativeandproceduralactivitiesasrequiredorrequested andto ensure that all assigned tasks are performed in compliance in accordance to the work instructions and GVP modules.
• Ensure that quality of case processing and assigned tasks are evaluated and trends are identified forprocess improvement.
• Various compliance metrics like case timelines, assigned trainings, and TAT for assigned activities aremet.
• Provide the analytical support to the peers and managers for investigations & analysis of various trendsas a part of audits, and inspections.
• Mentoring/Training the new hires with case processing knowledge transfer, evaluating their progressclose to perfection during their initial phases of learning curves.

Graduate/ Post graduate in registered life sciences

Min 3 - 4 years relevant experience

• Extensive knowledge of medical terminology, clinical pharmacology, patent treatment, diagnostic investigations and pathology.
• Sound knowledge of pharmacovigilance principles and international regulatory requirements related to drug and patient safety.
• Basic knowledge on TEVA product portfolio, their therapeutic area expertise, mechanism of actions and its product/ patent safety index.
• Possess excellent communications skills with professional English speaking, writing, presenting skills and must be detailed oriented.