Safety Systems Analyst II

Primary Responsibilities:

Execution of weekly, monthly and ad hoc reports from the PV database

Preform all required Quality Control (QC) and complete documentation

Assist with the execution and verification of Ethics Committee and Health Authority Periodic outputs

Maintain and distribute the Study Configuration Spreadsheet

Maintain and distribute applicable sections of the Data Entry Conventions and associated appendices

Track the development, testing, implementation and closure of all PV Systems requests

Assist PV Systems

Director with the following activities:

Maintenance and delivery of systems supporting the PV business unit, the primary focus is the Argus Safety Systems.

Monitoring of PV System vendor activities and ensuring compliance with contractual expectations

Maintaining documentation of system configuration and all subsequent changes

Validates and implements annual, periodic and ad-hoc reports in the Drug Safety systems

Maintaining the processes for systems in compliance with regulatory requirements and company standards

Skills:

Education/Experience/Skills

At least 4 years of experience in Pharmacovigilance Systems with at least 2 years of experience with data retrieval from the Oracle Argus Safety Database

Attention to detail, Critical thinking, Creative problem-solving, Collaborative approach, Proficient Computer Skills, including Microsoft Word and Excel

Knowledge of Drug Safety and Pharmacovigilance function

English (fluent verbal and written)

Required Skills:

Problem-Solving

Drug Safety

Database

Pharmacovigilance

Excel

Minimum Degree Required: Completed High School (Diploma or GED)

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.