QPPV Specialist - Pharmacovigilance

Main Job Tasks and Responsibilities:

• Provide high quality, balanced and timely information to requests for medical information from both internal and external customers.
• Prepare and revise Medical Information scientific responses using clinical experience and critical analysis of the clinical literature to create appropriate solutions.
• Maintain a database of the Medical Information requests and responses.
• Develop and maintain a current knowledge of products and disease states.
• Maintain references and other Medical Information resources.
• Receive and initially process product complaints; forward information to the Quality Assurance Manager.
• Prepare and conduct training to Sales and Marketing on company products.
• Review promotional material for adherence to advertising regulations and guidelines, and medical accuracy.
• Process adverse event information from clinical trials and spontaneous reports including clinical data entry into the electronic database.
• Ensure data accuracy, clinically valid case assessment, regulatory reporting status assessment, and follow-up is completed on pharmacovigilance cases.
• Report adverse events to the appropriate Regulatory Authorities, and clinical study personnel according to regulations and standard operating procedures.
• Maintain a log, compliance information and filing system for all pharmacovigilance cases.
• Provide pharmacovigilance training to internal staff, and external partners, as required.
• Actively participate in departmental and various cross-functional project teams that may include Regulatory, Sales and Marketing, and Medical Affairs.
• Participate in personal development and training sessions.