Sr. Safety & Pv Systems Specialist

2+ years

Not Disclosed

Remote - Europe

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

Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to drive outcomes that address modern market realities.

Our Clinical Development model puts customers and patients at the center of our efforts. We constantly seek ways to simplify and streamline our work, making Syneos Health not only easier to work with but also a more rewarding place to work.

Join us in either a Functional Service Provider partnership or a Full-Service environment, collaborating with passionate problem solvers. Together, we innovate to help our customers achieve their goals, driven by our commitment to accelerate the delivery of therapies and change lives.

Why Syneos Health

We prioritize the development of our people through career progression, supportive line management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters authenticity and unity, ensuring we take care of our people. By embracing diverse thoughts, backgrounds, cultures, and perspectives, we create a workplace where everyone feels they belong.

Job Responsibilities

General:

Maintain a repository of relevant documents, including training materials, project finance, proposals tracking, RFI Library, departmental metrics, and audit/inspection lists.
Develop and maintain Job Aids and process documents with supporting documentation as needed.
Stay updated on FDA/EU/ICH guidelines and regulations related to safety and PV reporting.
Work with operational SPVG team members and Therapeutic BU PMs/Project Directors to meet SPVG Annual Revenue targets.
Provide SPVG metrics as required.
Perform additional duties as assigned.
Travel up to 15% may be required.

Technology:

Participate in audits and system demos.
Engage in the implementation and validation of Safety Systems projects, including testing and documentation.
Develop and maintain departmental SOPs and WIs related to Safety Systems.
Understand IT SOPs and WIs impacting Safety Systems.
Analyze and assist with programs for regulatory or customer report needs from Safety Systems.
Enhance department efficiencies related to Safety and Pharmacovigilance processes.
Configure, administer, and maintain the Argus Safety database per project requirements.
Develop, validate, test, and maintain all Safety reporting tools (e.g., Business Objects).
Create and maintain Argus Project Information, Argus Product/Licenses, Argus User Access, and Report Request forms.
Troubleshoot issues with Argus and other Safety systems.
Develop Safety Systems and Argus-related training materials for end users and trainers.
Train and mentor junior Safety Application Specialists.
Advise and assist Safety users with alternate sponsor databases (e.g., ArisG, Clintrace).
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 quality check listings, reports, and queries from the safety database.
Represent Safety Applications team in project team and client meetings.
Maintain expertise in Safety & PvG systems through internal meetings and professional seminars.

Qualifications

Bachelor's degree in life science, nursing, pharmacy, computer science, technology, or equivalent experience.
Proficiency with Safety Database systems and medical terminology.
Extensive experience in clinical research, data collection/computer systems, or equivalent in the pharmaceutical or CRO industry.
Excellent computer skills and knowledge of relational databases. Preferred experience with Oracle Insight/Analytics/Data Mart, Crystal Reports/Business Objects, SQL Plus.
Strong understanding of ICH guidelines and safety/pharmacovigilance regulations.
Proficient in Microsoft Office Suite (Word, Excel, Visio, PowerPoint), Outlook, and internet.
Ability to work independently and in a team environment.
Excellent communication, presentation, and interpersonal skills.
Strong organizational and documentation skills.
Detail-oriented with the ability to meet deadlines.
Capable of effective decision-making and managing multiple priorities.
Minimal travel may be required.

Get to Know Syneos Health

In the past five years, we have collaborated with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients. At Syneos Health, you will take the initiative and challenge the status quo in a competitive and dynamic environment. Learn more about Syneos Health.

Additional Information: Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and education will also be considered, and qualifications may differ from those listed. The Company will determine what constitutes equivalent qualifications. This description does not create an employment contract. The Company complies with the Americans with Disabilities Act, providing reasonable accommodations to assist employees or applicants in performing essential functions of the job.