Sr Argus Systems Specialist

2+ years

Not Disclosed

Remote, USA

10 Nov. 18, 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

Senior Safety & Pharmacovigilance (PV) Operations Specialist

Syneos Health® is a leading biopharmaceutical solutions organization dedicated to accelerating customer success by integrating clinical, medical, and commercial insights to drive outcomes in the ever-evolving healthcare market. We are committed to simplifying and streamlining processes, aiming to make Syneos Health easier to work with, and even easier to work for.

As a Senior Safety & PV Operations Specialist, you will join a team of passionate problem-solvers who collaborate to bring therapies to market and improve patient lives. Whether working in a Functional Service Provider partnership or Full-Service environment, you will be part of a team focused on innovation, agility, and accelerating the delivery of therapies.

Why Syneos Health?

We are passionate about developing our people through career growth, supportive management, training programs, and peer recognition. Our Total Self culture allows you to authentically be yourself while being part of a global team that values diverse perspectives. This approach creates an environment where everyone feels they belong, enabling us to deliver superior results.

Key Responsibilities

General:

Develop and maintain a repository for key documents including training materials, safety project finance, and departmental metrics.
Facilitate the achievement of SPVG revenue targets by working closely with operational teams and Project Directors to ensure timely and accurate project recognition.
Provide SPVG metrics and updates at agreed intervals.
Perform additional work-related duties as assigned with minimal travel required (up to 15%).

Technology:

Configure, administer, and maintain Argus Safety databases for various projects, ensuring sponsor-specific requirements are met.
Participate in audits, system demos, and the validation of safety systems.
Support the creation and maintenance of departmental SOPs and work instructions.
Troubleshoot issues related to Argus and other safety systems, ensuring efficient operations and compliance with safety standards.
Assist in Safety System Data Migrations and the creation of custom reports.
Create and maintain relevant project information in Argus, ensuring data accuracy for internal and regulatory reporting.
Provide training and mentoring for junior specialists in Safety Applications.

Qualifications

Required:

Bachelor's degree in life science, registered nursing, pharmacy, computer science, or related technical field, or equivalent experience.
Experience with Safety Database systems, moderate medical terminology knowledge, and understanding of pharmacovigilance.
Proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint) and email (Outlook).
Strong organizational, communication, and interpersonal skills, with the ability to manage multiple priorities and tasks simultaneously.
Ability to make informed decisions and meet deadlines with a high degree of accuracy.

Preferred:

Experience with relational databases (Oracle Insight/Analytics/Data Mart, Crystal Reports, SQL Plus).
Deep knowledge of ICH guidelines and safety regulations.
Experience in the pharmaceutical or CRO industry, specifically in pharmacovigilance and clinical research.

About Syneos Health

With a global reach in over 110 countries, Syneos Health has worked on 94% of all FDA-approved novel drugs and 95% of EMA-authorized products. We’ve managed over 200 studies across 73,000 sites and 675,000+ trial patients. Our impact is meaningful, and every role contributes to improving patient outcomes.

Learn more about Syneos Health and how you can be part of our mission to accelerate innovation and healthcare worldwide.

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Sr Argus Systems Specialist

Job Description

Why Syneos Health?

Key Responsibilities

Qualifications

About Syneos Health

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