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Sr Argus Systems Specialist

2+ years
Not Disclosed
10 Nov. 29, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Cs/B.Pharm/M.Pharm/Life science 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

Senior Safety & PV Operations Specialist

Company: Syneos Health
Location: Global


About Syneos Health

Syneos Health is a global leader in biopharmaceutical solutions, blending clinical, medical affairs, and commercial expertise to deliver tailored results. The company emphasizes collaboration, innovation, and agility to bring therapies to market efficiently, with a mission to transform lives worldwide.


Job Summary

The Senior Safety & PV Operations Specialist is responsible for managing safety and pharmacovigilance (PV) processes, configuring safety databases, and ensuring compliance with regulatory and corporate standards. This role supports project teams and contributes to the overall efficiency of safety systems and operational workflows.


Responsibilities

General Tasks:

  • Maintain repositories of essential documents (e.g., training, proposals, metrics, audit reports).
  • Develop and manage job aids, process documents, and supporting materials.
  • Ensure familiarity with FDA, EU, and ICH guidelines and regulations for safety reporting.
  • Facilitate safety and pharmacovigilance goals by collaborating with operational and therapeutic teams.
  • Provide SPVG metrics and participate in other assigned tasks.
  • Minimal travel (up to 15%).

Technology & Safety Systems:

  • Configure and maintain Argus Safety database per project requirements.
  • Troubleshoot issues in Argus and other safety systems, offering user support.
  • Participate in safety systems implementation, validation, testing, and audits.
  • Maintain SOPs and Work Instructions for safety systems and related processes.
  • Develop tools for data migration, reporting, and custom queries.
  • Assist in creating and delivering training materials for safety systems.
  • Represent the Safety Applications team in project meetings and audits.
  • Maintain compliance with global regulations, GCP, and ICH guidelines.
  • Serve as an expert resource for safety database systems, including ArisG and Clintrace.

Qualifications

Education and Experience:

  • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, or a related field. Equivalent experience considered.
  • Proficiency with safety database systems and medical terminology.
  • Experience in clinical research, data collection, or related fields preferred.

Technical Skills:

  • Knowledge of Oracle Insight, SQL, Crystal Reports/Business Objects preferred.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio).
  • Expertise in safety systems (Argus, ArisG, Clintrace) and regulatory compliance.

Soft Skills:

  • Strong organizational, documentation, and decision-making abilities.
  • Ability to manage multiple tasks and prioritize effectively.
  • Excellent communication and interpersonal skills.

Why Syneos Health?

  • Impactful Work: Contribute to groundbreaking projects in partnership with leading biopharmaceutical companies.
  • Growth Opportunities: Access tailored training programs, career development, and mentorship.
  • Inclusive Culture: Thrive in a supportive environment that values diversity and authenticity.

Additional Information

  • Flexibility: Tasks and duties may evolve based on organizational needs.
  • Compliance: The company ensures ADA accommodations for employees and applicants.

How to Apply

Join a dynamic team that’s transforming lives through innovative therapies. Apply now or connect with Syneos Health’s Talent Network for future opportunities.

Syneos Health encourages applicants from diverse backgrounds and considers transferable skills for all roles.