Retrieve case data from PV Intake Server and perform reconciliation of all inbound correspondence(s). Prepare metrics report by collecting, analyzing and providing to leadership as appropriate per client requirement(s). Handle inbound and outbound correspondence and query management. Data entry of adverse event (AE) cases into the respective safety databases.
Principal Responsibilities: (Essential Function): include all or majority of the following below. Other duties may be assigned.
Monitor inbound safety information and process as applicable. Perform reconciliation of all inbound correspondence.
Perform data entry functions as per program requirement.
Prepare metric reports by collecting, analyzing and providing to leadership as appropriate per client requirement.
Send out letter and data clarification forms (DCF), as necessary.
Control all documents filed then archive or return to client as applicable.
Assist with the development of procedural documents to support Pharmacovigilance activities.
Perform responsibilities in accordance with Standard Operating Procedures (SOP) and Work Instructions (WI).
Maintain paper and/or electronic filing systems of all communications with clients.
Participate in quality assessment reviews and audits as required.
Ensure team closures of non-conformances (NC) and Corrective Action Preventative Actions (CAPA) in a timely manner.
Participate in validation sessions as necessary.
Mentor, train and update new and existing staff on client information.
Inform appropriate staff of delayed, missing or incomplete items; ensure follow up and completion of all transactions in a timely manner.
Specialized intellectual instructions (certificate program/college courses) with related experience or relevant equivalent experience or Associate’s degree preferred. Previous pharmacovigilance experience is a plus.
Must be proficient in Microsoft Office Products. Argus safety database a plus.
Ability to read, analyze and interpret general and business periodicals, professional journals, technical procedures or governmental regulations.
Write reports, business correspondence and procedural manuals
Effectively present information and respond to questions from groups of leadership, clients, customers and the general public.
Ability to define problems, collect data, establish facts and draw valid conclusions and to interpret an extensive variety of technical instructions in mathematics or diagram form.
Deal with several abstract and concrete variables.
Must possess excellent written, verbal, and presentation skills.
Must have strong analytical skills.
Organizational and time management skills, with the ability to prioritize tasks is a must to meet very tight deadlines.
Flexibility in accepting responsibilities to meet the needs of the client and team’s goals.
C3i Solutions is a world-wide business process outsourcer specializing in the multi-channel engagement of consumers, patients, healthcare professionals and enterprise personnel via a network of global contact centers.
Our unique customer-centric approach has made C3i Solutions the partner of choice for some of the world’s most trusted brands for more than 30 years. C3i Solutions provides unpa...ralleled 24/7 support to customers in over 100 countries speaking 30 different languages.
With strategic focus on innovation and regulatory compliance, C3i Solutions handles more than 35 million interactions per year, helping our clients build and protect their brands while maximizing productivity and cost efficiencies. More than 90 percent of the company’s clients are FDA-regulated.