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: Case processing: 95% Definition: The completion of full case information on the database, including quality review to ensure accuracy and completeness Activities Include: • May Triage and classify ICSRs for report type, seriousness, causality, expectedness/labeling and reporting; prioritize ICSR according to regulatory requirements • Confirmation of Safety Coordinator case registry data • Database searches as necessary • Completion of remaining case data entry, including narrative or auto-narrative • Completion of risk and quality (label, approval, manual coding and quality review steps). • Clarification of unclear or illegible information from the LSO or Call Centre • Discussion of source documents, coding conventions and ad-hoc queries with Pharmacovigilance Physician • Request deletions as necessary • Single case unblinding Processes & Procedures: Definition: Continuing awareness of company procedures and guidelines to maintain regulatory compliance Activities Include: • Standard Operating Procedures and Working Instructions • Department guidance documents • MedDRA coding dictionary and MedDRA Points to Consider • Understand relevant safety implications regarding contracts with operating companies and/or marketing partners DECISION-MAKING AND PROBLEM-SOLVING: Application and knowledge of Departmental processes and guidelines, regulations and regulatory guidelines, contractual arrangements, product specific information and database/systems functionality to individual case processing and evaluation. Communicate questions clearly and concisely to the appropriate audience and accompany with possible solutions. REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides. Supervised by Senior DSA WORKING RELATIONSHIPS/INTERFACES: Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature. Global Medical Safety Operations (GMSO) is a functional area within the Global Medical Organization (GMO) All others in GMSO Medical Affairs Clinical Affairs Contract Research Organizations Local Safety Officers Marketing Partners
EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable. • Registered Nurse OR • Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification) OR • Licensed Practical Nurse without Bachelors degree but with knowledge of Drug Safety usually exhibited by minimum 5 years experience in pharmaceutical safety-related role. • Pharmaceutical industry experience is preferred
Required Skills/Abilities • Intermediate Information Technology Skills • Data entry experience desired • Accountability for delivery of results • Decision making skills • Problem solving skills • Proactive approach/uses own initiative • Manages owe work, able to prioritize, plan and organize work assignments and work under strict timelines • Ability to follow guidelines, working practices etc. Experience of working with SOP/WI preferred • Quality oriented, with attention to detail/accuracy • Flexibility/Adaptability • Positive attitude • Good team player • Ability to work independently and to collaborate • Good written and verbal communication skills • Understanding of medical terminology • Ability to summarize medical information
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