Safety Analyst II

Steneral Consulting • Princeton, NJ, US • 4m ago

3 days onsite each week, must be local and under 60 mins

Need active and Valid LinkedIn

Need Visa copy for non USC and photo ID for USC ( no info must be hidden/blacked out as they wont be considered)

Must be Independent

Possible CTH role

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

Required Skills

PROBLEM-SOLVING

DRUG SAFETY

DATABASE

PHARMACOVIGILANCE