Safety Systems Analyst Ii (Pharmacovigilance)

4+ years

Not Disclosed

Princeton Junction

12 June 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Safety Systems Analyst II

Employer: Aequor

Category: Safety

Location:

Country: United States
State: New Jersey (NJ)
City: Princeton

Job Code: 24-01643

Post Date: 06/06/2024

Description:

Job Title: Safety Systems Analyst II

Scope of Role: Responsible for supporting the maintenance of the Pharmacovigilance (PV) database and performing PV database data retrieval activities.

Primary Responsibilities:

Execute weekly, monthly, and ad hoc reports from the PV database.
Perform 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 various activities related to maintaining and delivering systems supporting the PV business unit, with a primary focus on the Argus Safety Systems.
Monitor PV System vendor activities and ensure compliance with contractual expectations.
Maintain documentation of system configuration and all subsequent changes.
Validate and implement annual, periodic, and ad-hoc reports in the Drug Safety systems.
Maintain 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.
Fluent in English (verbal and written).

Keywords:

Problem-Solving
Drug Safety
Database
Pharmacovigilance
Excel

Languages:

English: Read, Write, Speak

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

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Safety Systems Analyst Ii (Pharmacovigilance)

Job Description

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