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)