Drug Safety Systems Specialist

Proclinical, in support of our client, are seeking an individual to fill the role of Drug Safety Systems Specialist based in Waltham, MA. The successful individual will lead safety data strategies and practices and other critical pharmacovigilance data analytical solutions needed for the complex pharmacovigilance/benefit-risk management function.

Responsibilities

• Provide subject matter expertise in Argus to ArisG migration.
• Develop, maintain, and document PV applications for data processing or retrieval and system requirements.
• Oversee and manage database validations and coding dictionary updates.
• Establish, enhance and perform activities to ensure the integrity and consistency of safety data
• Ensure that pharmacovigilance data query results are well defined and delivered in a timely and compliant manner.
• Develop, implement, and distribute routine and ad-hoc data queries for internal metrics, forecasting or regulatory submission purposes.
• Develop, lead and prioritize projects.
• Interface with external and internal partners.
• Assist with the development and/or updates of SOPs, Work Instructions, forms, conventions or other internal documents as needed.

Skills and Qualifications

• BA (MA Preferred) in technology, computer engineering or computer science and 5-7 years of experience in drug development.
• Extensive experience in ArisGlobal Lifesphere platform including Lifesphere safety and Intake and Triage.
• Expert knowledge of drug safety database (ARISg) and E2b reporting.
• Expert knowledge of data reporting/visualization tools.
• Expert knowledge of regulatory requirements as applied to single case and aggregate safety data management, E2B submissions and 21 CFR Part 11 compliance.
• Excellent written and oral communication skills, including written and spoken English fluency.
• Strong proficiency in Microsoft Office suite.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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