Sr. Safety & Pv Systems Specialist

2+ years

Not Disclosed

Remote, USA

10 July 22, 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, 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

About Syneos Health® Syneos Health® is a premier, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address modern market realities, placing the customer and patient at the core of our Clinical Development model. Our aim is to simplify and streamline our processes to enhance collaboration and efficiency for both our clients and employees.

With a workforce of 29,000 across 110 countries, we embrace a collaborative spirit, bringing together passionate problem solvers to deliver innovative solutions. Our commitment is driven by the desire to expedite the delivery of therapies and ultimately, to change lives.

Why Syneos Health? We are deeply committed to the growth and development of our employees through career advancement opportunities, supportive management, specialized training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters authenticity and inclusivity, creating an environment where everyone feels they belong. We believe in the power of diversity in thoughts, backgrounds, cultures, and perspectives to build a workplace that is both enriching and engaging.

Job Responsibilities

General Duties

Maintain a repository of essential documents (e.g., Training, Safety, Pharmacovigilance Project Finance, Proposals tracking, RFI Library, departmental metrics, audits/inspections lists).
Develop and update Job Aids and process documents, ensuring supporting documentation is available.
Stay informed on FDA/EU/ICH guidelines and regulations related to safety and PV reporting.
Collaborate with SPVG team members and Therapeutic BU PMs/Project Directors to achieve SPVG Annual Revenue targets.
Provide SPVG metrics at agreed intervals and perform additional tasks as assigned.
Travel requirements are minimal (up to 15%).

Technology Duties

Participate in audits and system demonstrations.
Assist in the implementation/validation of Safety Systems projects, including testing and documentation.
Develop and maintain departmental SOPs and Work Instructions related to Safety Systems.
Understand IT SOPs and WIs affecting business processes associated with Safety Systems.
Assist with regulatory or customer report needs from Safety Systems and improve departmental efficiencies.
Configure, administer, and maintain the Argus Safety database per project requirements.
Develop, validate, test, and maintain Safety reporting tools (e.g., Business Objects).
Create and manage Argus Project Information, Product/Licenses, User Access, and Report Request forms.
Troubleshoot issues related to Argus and other Safety systems.
Develop training materials for Safety Systems and Argus-related training for End Users and functional area trainers.
Mentor junior Safety Application Specialists and advise on the use of alternate sponsor databases.
Ensure compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, and the drug development process.
Plan, write, and execute Safety System Data Migrations and custom reports.
Generate and perform quality checks on listings, reports, and queries from the safety database.
Represent the Safety Applications team at project team and client meetings.
Maintain expertise in Safety & PVG systems and applications through internal meetings and professional development.

Qualifications

Bachelor's degree in life science, registered nurse, pharmacist, computer science, technology-related field, or equivalent combination of education and experience.
Experience with Safety Database systems and medical terminology.
Background in clinical research, data collection/computer systems, or equivalent experience in the pharmaceutical or CRO industry.
Proficiency in computer skills and relational databases. Preferred experience with Oracle Insight/Analytics/Data Mart, Crystal Reports/Business Objects, and SQL Plus.
Strong understanding of ICH guidelines and safety and pharmacovigilance regulations.
Proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint), email (Outlook), and internet.
Ability to work independently and collaboratively.
Excellent communication, presentation, and interpersonal skills.
Strong organizational, documentation, and multitasking abilities.
Detail-oriented with the ability to meet deadlines.
Effective decision-making and priority management skills.
Minimal travel may be required.

About Syneos Health Over the past five years, we have partnered with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites and 675,000+ trial patients.

Join us in challenging the status quo in a dynamic environment. Learn more about Syneos Health and discover why work here matters everywhere.

Additional Information Tasks and responsibilities outlined in this job description are not exhaustive. The Company may assign other tasks, duties, and responsibilities at its discretion. Equivalent experience, skills, and/or education will be considered for qualification purposes. This document should not be construed as an employment contract. Syneos Health is committed to compliance with the Americans with Disabilities Act and will provide reasonable accommodations when appropriate to assist employees or applicants in performing the essential functions of the job.

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