Sr Safety & Pv Ops Specialist- Argus Administrator

2+ years

Not Disclosed

Remote - Europe

10 Oct. 16, 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, 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 & Pharmacovigilance Operations Specialist

Syneos Health® is a premier fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that meet modern market needs.

Our Clinical Development model places both the customer and the patient at the center of everything we do. We continuously seek ways to simplify and streamline our processes, making Syneos Health easier to work with and for.

Join us, and collaborate with passionate problem solvers who innovate as a team to help our customers achieve their goals. We are agile and driven to expedite the delivery of therapies, united by our passion to change lives.

Discover What Our 29,000 Employees Across 110 Countries Already Know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are committed to developing our people through career progression, supportive management, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture encourages you to be your authentic self, fostering a global environment where everyone feels they belong.

Job Responsibilities

General:

Develop and maintain a repository of relevant documents, including training materials, project finance, proposal tracking, departmental metrics, and audit lists.
Create and maintain job aids and process documents, ensuring all supporting documentation is up-to-date.
Stay informed on FDA/EU/ICH guidelines and regulations related to safety and pharmacovigilance (PV) reporting.
Collaborate with operational teams to facilitate SPVG Annual Revenue targets and ensure accurate recognition.
Provide SPVG metrics at agreed intervals based on assigned tasks.
Perform additional work-related duties as assigned, with minimal travel (up to 15%).

Quality & Compliance:

Support quality planning and compliance activities by providing controlled document support and tracking quality metrics.
Identify and communicate areas of risk and provide expertise for quality improvement support.
Assist safety project teams in maintaining audit and inspection readiness.

Training:

Plan, develop, and present training materials for the Safety and Pharmacovigilance Business Unit, collaborating with leadership to ensure content accuracy.
Oversee the Learning Management System (LMS) for Safety and Pharmacovigilance.
Develop PV-specific training for accreditation programs.

Technology:

Participate in audits and system demos as needed.
Engage in the implementation and validation of Safety Systems projects, including testing and documentation.
Contribute to the development and maintenance of departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to Safety Systems.
Configure, administer, and maintain the Argus Safety database, ensuring sponsor requirements are met.
Troubleshoot issues related to Argus and other Safety systems.
Create and maintain Argus project information and report request forms.
Generate quality checks for reports and listings from the safety database.

Proposals:

Collaborate with operational teams to facilitate SPVG Annual Gross Profit targets and develop proposal strategies.
Ensure the accuracy of SPVG budget, text, and scope for responses to RFPs and RFIs.
Maintain and update proposal templates and the costing model for SPVG.

Qualifications

What We’re Looking For:

Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or a related technical field, or equivalent combination of education and experience.
Experience with safety database systems and medical terminology.
Extensive clinical research experience and familiarity with principles and standards in the pharmaceutical or CRO industry.
Proficiency in relational databases and software such as Oracle Insight, Crystal Reports, Business Objects, and SQL.
Strong knowledge of ICH guidelines and regulations related to safety and pharmacovigilance.
Excellent skills in Microsoft Office Suite (Word, Excel, PowerPoint), email (Outlook), and internet applications.
Ability to work independently and collaboratively within a team environment.
Strong organizational, documentation, and communication skills, with a keen attention to detail.
Ability to prioritize and manage multiple tasks and projects effectively.

Get to Know 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 and 675,000+ trial patients.

No matter your role, you’ll have the opportunity to challenge the status quo in a competitive and dynamic environment. Learn more about Syneos Health.

Additional Information: This job description is not exhaustive; the company may assign additional tasks as needed. We consider equivalent experience and qualifications. Our commitment to diversity and inclusion is paramount, and we comply with all relevant employment legislation, including the Americans with Disabilities Act.

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At Syneos Health, we value diverse perspectives. If your experience doesn’t align perfectly, we still encourage you to apply, as transferable skills are important to us.