Sr Safety & Pv Ops Specialist- Argus Administrator

2+ 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

Senior Safety & PV Operations Specialist

Company Overview:

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

Our Clinical Development model centers around the customer and patient, continually seeking to streamline processes to enhance collaboration and efficiency. At Syneos Health, you’ll join a team of passionate problem solvers, committed to innovating and delivering therapies that change lives.

Why Work with Us:

At Syneos Health, we prioritize career development and progression through supportive management, training, peer recognition, and comprehensive rewards. We embrace a Total Self culture, fostering an inclusive environment where diverse backgrounds and perspectives unite to create a sense of belonging.

Key Responsibilities:

General

Develop and maintain a comprehensive repository of documents (training materials, project finance, proposal tracking, departmental metrics, audit/inspection lists).
Create and manage job aids and process documentation.
Stay updated on FDA/EU/ICH guidelines and regulations related to safety and pharmacovigilance (PV) reporting.
Collaborate with operational teams to meet SPVG Annual Revenue targets and ensure timely recognition in RBB.
Provide SPVG metrics at agreed intervals and perform additional duties as assigned.
Some travel may be required (up to 15%).

Quality & Compliance

Support quality planning and compliance by managing controlled documents and tracking quality metrics.
Conduct risk assessments and liaise with Corporate Quality Assurance (CQA) to resolve quality issues.
Assist safety project teams in maintaining audit and inspection readiness.

Training

Develop, track, and present training materials for the Safety and Pharmacovigilance BU, collaborating with leadership to ensure content relevance.
Oversee the Learning Management System (LMS) for Safety and Pharmacovigilance.
Create PV-specific training for accreditation programs.

Technology

Participate in audits and system demos, and support the implementation/validation of Safety Systems projects.
Maintain departmental SOPs and Work Instructions (WIs) related to Safety Systems.
Administer and maintain the Argus Safety database, ensuring compliance with sponsor-specific requirements.
Troubleshoot issues with Argus and other Safety systems, while assisting in the development of training materials for users.
Engage in Safety System Data Migrations and generate quality checks for internal and regulatory reports.

Proposals

Collaborate with operational teams to understand factors driving SPVG Annual Gross Profit percentage (GP%).
Develop proposal strategies and ensure accuracy of budgets, texts, and scope of work for RFPs and RFIs.
Maintain and update template proposal text and assist in budget changes as necessary.

Qualifications:

Bachelor’s degree in life science, nursing, pharmacy, computer science, or a related field; equivalent experience is also acceptable.
Knowledge of safety database systems and medical terminology is essential.
Experience in clinical research, data collection, or related areas within the pharmaceutical or CRO industry is preferred.
Proficiency in relational databases and analytical tools (Oracle Insight, Crystal Reports, SQL Plus) is advantageous.
Strong understanding of ICH guidelines and safety regulations.
Proficient in Microsoft Office Suite and other essential software.
Ability to work independently and in a team environment, manage multiple priorities, and communicate effectively.

Get to Know Syneos Health:

In the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites, impacting over 675,000 trial patients. Join us in challenging the status quo in a dynamic environment.

Additional Information:

The responsibilities listed in this job description are not exhaustive. Syneos Health may assign additional tasks as needed. We are committed to compliance with the Americans with Disabilities Act and will provide reasonable accommodations to assist employees in performing their essential job functions.