Pharmacovigilance Associate

 Description:

• Identify and collect adverse event information and complete the in-take of a Pharmacovigilance Safety Report in Client Safety Systems through a thorough telephonic patient assessment and evaluation of information

• Ensure scientific rigor through accurate, complete and consistent data entry of medical information through numerous adverse event reports and notes with emphasis on timeliness and quality in order to meet regulatory demands

• Review and evaluate case information for medical completeness and accuracy prior to the appropriate completion of processing through pushing, triaging or escalation of all AE reports within a rigid regulatory mandated timeframe

• Respond to medical information requests using approved resources and documentation in Client medical information systems

• Identify product quality and device complaints and document in Client s product/device complaint systems

• Compliance with departmental guidelines, SOPs, ongoing training, and regulatory guidelines

• Effectively communicate by actively listening to acquire information and understand another's viewpoint to communicate clearly and establish rapport with customers, colleagues, and interdepartmental groups

• Strong verbal communication skills with external and internal customers

• Prepare and communicate timely and accurate information with customers using various platforms

• Understands and assimilates information to accurately respond to situations by providing fair and unbiased scientific data to customers

• Completes follow up reports and response documentation in a timely, concise, and objective manner

• Use of multiple databases to document adverse event, medical information, and product complaint information

• Identify and communicate possible issues to Team Leaders and Manager

• May assist in training others on specific, non-complex, process or database

• Co-ordinate with team on problem solving and improvement initiatives

• Responsible for completion of day-to-day work and process flows within the agreed service levels (SLAs)