There are currently 2 open positions. One is a full-time and the other a part-time for 19 hours per week. Both are 6 month contract positions with a large pharma company.
Position Summary: Responsible for the receipt and data entry of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies
Principal Responsibilities include: Data management, report preparation and appropriate dissemination of spontaneous non- serious and serious adverse event information for legacy consumer healthcare products. Activities include: Duplicate check and commit contact information from initial and follow-up source documents into the adverse event database Forward cross reference email with assigned data base number to reporter for ex-US contacts Prepare a clinical narrative (CIOMS/3500A) and independently assign MedDra terms and labeling to adverse events while maintaining compliance timelines *Liaise with the SA point person for Triage *Quality review is limited to review of their own work Requests deletions as necessary Supports aggregate report writing via data integrity changes All other duties as assigned * Clarification to original job description
Processes and Procedures Definition: Understand and follow BRM systems and procedures SOP: Standard operating procedure awareness SWP: standard working practice awareness Guidance Documents Forms
Requirements:
Education & Experience requirements: Required education/Training and/or Experience: Bachelor of Science degree in health arena (a must!) Previous experience using medical terminology and MedDra coding desired Applied knowledge of global regulations and global compliance timeline desired
Required Skills/Abilities: A working knowledge of data management systems Excellent oral and written skills Decision making skills Managing own work Ability to follow guidelines Quality orientation Flexible/adaptable Positive attitude Team player Ability to work to collaborate 3 years experience
