Pharmacovigilance Case Manager — Adverse Event Specialist

Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at . Job Description Job Title: Case Management Associate Job Duration: 18 months + Job Location: Indianapolis, IN, United States JOB

DETAILS:

Manage adverse event reporting. Stay current regarding FDA and global regulations with respect to safety reporting and pharmacovigilance. Ensure regulatory compliance for expedited submission of case reports. Maintain an understanding of current labeling practices (e. g. , USPI, Core, CIP and EUSPC). Interact with internal and external customers. Provide support regarding Global Product Safety (GPS) policies, processes and procedures. Support product safety surveillance activities. Education: Bachelor's degree(or higher) in a healthcare-related field or life sciences field or demonstrated equivalent experience is required Demonstrates basic clinical knowledge of various disease states Effective communication skills (verbal and written) Demonstrates competency in IT platforms including databases, Microsoft Office, and CLIENT web based collaboration sites Ability to manage multiple concurrent tasks; good organizational skills, attention to detail; ability to focus for long periods of time on detailed information; consistently prioritizes work and makes decisions that comply with applicable timelines Effectively analyzes possible solutions to solve a range of problems Effectively responds to customer requirements and requests English language skills — fluent written and verbal communications Knowledge of global regulations with respect to adverse event reporting Knowledge and understanding of GPS policies and procedures Ability to learn quickly and adapt to a changing environment Flexibility to adapt to changing priorities Demonstrated interpersonal skills; ability to work as part of a team Ability to see the big picture; use logic to solve problems Primary Position Responsibilities (major or daily tasks) Purpose: The purpose of the Associate/Senior Associate/Associate Consultant Case Management (Case Manager) role is to be responsible for adverse event report handling. This includes assessing and processing individual adverse event reports; maintaining awareness of global pharmacovigilance regulations; ensuring regulatory compliance for expedited submission of individual case reports; collaborating with internal and external business partners as well as other duties as assigned. An associate's responsibilities can vary depending on the needs and focus of a particular team as well as the global case manager competency model. Responsibilities: Adverse Event Case Management: Responsible for review, entry, assessment, and acknowledgement of adverse event reports in the safety database Develop an understanding/expertise of pharmacovigilance regulations Comply with internal and external timelines for managing adverse event data entry and expedited reporting processes as appropriate Creation of a case narrative Attempt to obtain follow-up information from external parties through effective written and oral communications Perform typical case management assessment activities which include (but not limited to): o Select individual adverse event terms o Code events to appropriate MedDRA terms o Manage and assess appropriate serious outcome criteria for adverse events o Assess listed ness - evaluate the case against the appropriate product information o Determination of whether medical physician safety review is necessary. o Determine what, if any, follow-up information is needed Global Support: Keep current on global regulatory issues and practices related to GPS Understand and apply GPS business practices Collaboration/Support Internal and External Customers Communicate effectively with CLIENT Corporate contacts from affiliate offices, call center contacts, legal, customer response teams, and other customer groups Understand the confidential nature of company information and take necessary steps to ensure its protection Qualifications bachelors , RN( registered nurse) Additional Information By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply #J-18808-Ljbffr Mindlance, Inc.