Sr Argus Systems Specialist

5+ years

Not Disclosed

Remote, USA

10 Nov. 21, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

Job Title: Senior Safety & PV Operations Specialist

Company: Syneos Health®

Location: [Location]

Job Overview:
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success. We are seeking a Senior Safety & PV Operations Specialist to join our team and contribute to the development, maintenance, and execution of safety solutions for pharmaceutical companies. This role involves managing and improving safety systems, participating in audits, and collaborating with cross-functional teams to ensure compliance with global regulations. If you are passionate about patient safety and operational excellence, we want you on our team.

Key Responsibilities:

General:

Develop and maintain safety-related documentation such as training materials, proposals, project finance tracking, and audit lists.
Support the achievement of Annual Revenue targets through coordination with operational teams and project managers.
Monitor and report on key metrics related to safety and pharmacovigilance processes.
Perform other tasks as required to support the broader safety and pharmacovigilance team.

Technology:

Configure, administer, and maintain the Argus Safety database to meet project-specific needs.
Assist with audits, system demos, and the implementation and validation of safety systems.
Support the development and maintenance of departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to Safety Systems.
Analyze and assist with internal and external regulatory or customer report requirements from safety systems.
Troubleshoot issues related to Argus and other safety systems.
Help with the development of training materials for safety systems and provide mentorship to junior specialists.
Ensure compliance with relevant global regulations and guidelines, including ICH and FDA/EU requirements.
Contribute to data migrations and custom report generation, and represent the Safety Applications team in project meetings.

Minimum Required Education and Experience:

Bachelor's degree in life sciences, registered nursing, pharmacy, computer science, or a related field (or equivalent experience).
Strong background in safety database systems, medical terminology, and clinical research.
Proficiency with relational databases, Oracle Insight/Analytics, Crystal Reports, Business Objects, and SQL Plus (technical role).
In-depth knowledge of ICH guidelines and pharmacovigilance regulations.
Expertise in Microsoft Office Suite and email communication tools.
Ability to work independently and as part of a collaborative team, prioritizing multiple tasks and deadlines.
Excellent communication, presentation, and organizational skills, with attention to detail and accuracy.

About Syneos Health:

Syneos Health® is a biopharmaceutical solutions organization that works with pharmaceutical companies globally to accelerate the development and commercialization of innovative therapies. We are committed to diversity, inclusion, and making a meaningful impact in healthcare. Join our team of passionate problem-solvers to help us drive change in the industry.

Learn more: Syneos Health Careers

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Sr Argus Systems Specialist

Job Description

Key Responsibilities:

General:

Technology:

Minimum Required Education and Experience:

About Syneos Health:

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