Sr Argus Systems Specialist

2+ years

Not Disclosed

Remote, USA

10 Nov. 18, 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, 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: [Insert location if applicable]
Slug URL: senior-safety-pv-operations-specialist-syneos-health

Description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but also to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health:

We are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and our total rewards program.
We are committed to our Total Self culture, where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we create a place where everyone feels like they belong.

Job Responsibilities

General:

Develop and maintain a repository of all relevant documents (e.g., Training, Safety and Pharmacovigilance Project Finance, Proposals tracking [awards and losses], RFI Library, departmental metrics, lists of audits/inspections).
Develop and maintain Job Aids and process documents, ensuring supporting documentation is updated as needed.
Maintain knowledge of FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
Facilitate SPVG Annual Revenue targets in collaboration with SPVG team members and Project Managers, ensuring accurate and timely revenue recognition.
Provide SPVG metrics as appropriate at agreed intervals.
Perform other work-related duties as assigned.
Minimal travel (up to 15%).

Technology:

Configure, administer, and maintain the Argus Safety database on a per-project basis to meet sponsor-specific requirements.
Participate in audits and system demos when necessary.
Support Safety System implementations and validations (including testing and documentation).
Develop and maintain departmental SOPs and Work Instructions related to Safety Systems.
Analyze and assist with reporting needs from Safety Systems for regulatory or customer purposes.
Implement efficiencies related to Safety and Pharmacovigilance processes.
Develop, validate, test, and maintain Safety reporting tools (e.g., Business Objects).
Troubleshoot all issues regarding Argus and other Safety systems.
Assist in the development of Safety Systems training materials.
Train and mentor junior Safety Application Specialists.
Perform other tasks as necessary related to Safety Systems.
Ensure compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, and the drug development process.
Participate in planning, writing, and execution of Safety System Data Migrations and custom reports.
Generate and perform quality checks on reports and listings from the safety database for internal, client, or regulatory use.
Represent Safety Applications at project team and client meetings.
Maintain expertise in Safety & PV systems through professional seminars and workshops.

Qualifications

What we’re looking for:

Bachelor's degree in Life Sciences, Nursing, Pharmacy, Computer Science, or related technical field, or an equivalent combination of education and experience.
Experience with Safety Database systems and moderate knowledge of medical terminology.
Extensive experience in clinical research, data collection/computer systems, or equivalent experience in the pharmaceutical/CRO industry.
Proficiency in Oracle Insight, Analytics/Data Mart, Crystal Reports/Business Objects, SQL Plus preferred.
Strong knowledge of ICH guidelines and regulations relating to safety and pharmacovigilance.
Proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint, Outlook).
Ability to work independently and in a team.
Excellent organizational, communication, and documentation skills.
Detail-oriented, with a high degree of accuracy and ability to meet deadlines.
Ability to manage multiple priorities.
Minimal travel required.

About Syneos Health:

Over the past 5 years, Syneos Health has worked with 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites with 675,000+ trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Additional Information:

Tasks and responsibilities may vary, and the company may assign other duties as needed. Equivalent experience, skills, and/or education will be considered, and nothing in this description should be construed as creating an employment contract.

Syneos Health is committed to compliance with all applicable laws, including the Americans with Disabilities Act (ADA).

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Sr Argus Systems Specialist

Job Description

Why Syneos Health:

Job Responsibilities

General:

Technology:

Qualifications

About Syneos Health:

Additional Information:

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