Sr Safety & Pv Ops Specialist- Argus Administrator

5+ years

Not Disclosed

Remote - Europe

10 Oct. 14, 2024

Job Description

Job Type: 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

Job Description: Senior Safety & Pharmacovigilance Operations Specialist

Company Overview

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 navigate modern market challenges effectively.

Our Clinical Development model prioritizes both the customer and the patient in all we do. We continually seek ways to simplify and enhance our processes, ensuring that Syneos Health is not only easier to work with but also a better place to work.

Join us in either a Functional Service Provider partnership or a Full-Service environment, where you’ll collaborate with passionate problem solvers, driving innovation as a team to help our customers achieve their objectives. We are agile, focused on expediting the delivery of therapies, and committed to making a meaningful difference in lives.

Why Syneos Health?

At Syneos Health, we are committed to the growth of our people through career development opportunities, supportive management, specialized training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters an environment where everyone can be authentic. We are dedicated to cultivating a workplace that embraces diversity of thought, background, and perspective, creating an inclusive atmosphere for all.

Job Responsibilities

General

Maintain a comprehensive repository for key documents, including training materials, project finance documentation, and departmental metrics.
Develop and sustain job aids and process documents, ensuring supporting documentation is up to date.
Stay informed on FDA/EU/ICH guidelines and regulations related to safety and pharmacovigilance reporting.
Collaborate with operational teams to facilitate annual revenue targets and ensure timely project recognition.
Provide metrics at agreed intervals based on assigned responsibilities.
Perform other related duties as assigned, with minimal travel (up to 15%) required.

Quality & Compliance

Support quality planning by managing controlled document revisions and tracking quality metrics to ensure compliance.
Engage in quality assurance activities, identifying risks through assessments and collaborating with management to resolve quality issues.
Aid project teams in maintaining readiness for audits and inspections.

Training

Design, develop, and present training materials for the Safety and Pharmacovigilance business unit.
Oversee the Learning Management System (LMS) for safety and pharmacovigilance training initiatives.
Create pharmacovigilance-specific training for accreditation programs.

Technology

Participate in system audits and demonstrations as needed.
Engage in the implementation and validation of safety systems, documenting all processes.
Develop and maintain departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs) for safety systems.
Configure and maintain the Argus Safety database, ensuring compliance with project-specific requirements.
Troubleshoot issues related to safety systems and assist with user training.
Maintain expertise in safety and pharmacovigilance systems through ongoing professional development.

Proposals

Collaborate with operational teams to achieve annual gross profit targets, ensuring comprehensive understanding of budget drivers.
Contribute to proposal strategies and ensure accuracy in RFP and RFI responses.
Assist in maintaining proposal templates and updating costing models to reflect realistic project information.

Qualifications

Education & Experience

Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or a related field, or equivalent combination of education and experience.
Familiarity with safety database systems and medical terminology is essential.
Extensive experience in clinical research, data collection, or related fields preferred.

Skills

Strong computer skills and knowledge of relational databases, with experience in Oracle Insight, Crystal Reports, and SQL preferred.
In-depth knowledge of ICH guidelines and safety regulations.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and email tools.
Ability to work independently and collaboratively in a team setting.
Exceptional organizational skills with a keen eye for detail and accuracy.
Strong communication and presentation skills, both written and verbal.
Capacity to prioritize tasks and manage multiple projects simultaneously.

About Syneos Health

Over the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, conducting over 200 studies across 73,000 sites with more than 675,000 trial patients.

Regardless of your role, you’ll be encouraged to take initiative and challenge the status quo in a dynamic environment. Learn more about us at Syneos Health.

Additional Information:
The duties and responsibilities outlined in this job description are not exhaustive. The Company reserves the right to assign additional tasks as needed. Equivalent experience and education will be considered. This description complies with applicable laws, including the Americans with Disabilities Act, ensuring reasonable accommodations are provided when necessary.