Safety Systems, Contractor

The Steely Group; Boston (MA); On-site; USD 96,000 - 145,000; Full time

Job summary

The Steely Group is seeking a Contractor, Safety Systems to support Global Safety Systems administration, configurations, user access, and reporting rules, with a strong understanding of pharmacovigilance and Oracle Argus.

In this role you will lead onboarding/offboarding for PV vendors, configure studies and licenses, troubleshoot issues, and develop data queries and reports to support safety operations and regulatory compliance.

Qualifications

• 8+ years of safety systems experience (e.g. Argus/Aris/Veeva) in maintenance, interface and reporting tools
• Bachelor/Advanced degree in life science or healthcare field
• Strong project management and stakeholder communication skills
• Good understanding of pharmacovigilance practices and regulatory standards

Responsibilities

• Maintain and configure Global Safety Systems including code lists, libraries, reporting rules and data validations
• Onboard/offboard PV vendors and manage access to PV SharePoint sites and distributions lists
• Lead safety systems projects, system upgrades and configurations
• Create queries/reports to support PV needs (aggregate, signal, study, ad hoc reports)
• Troubleshoot safety systems issues and coordinate with vendors for resolutions

Skills

Safety Systems

Pharmacovigilance

Project management

Customer service

Communication skills

SQL

Education

Bachelor's or advanced degree in life science

Tools

Argus

Aris Global

Veeva

IQVIA PVQ

RxLogix PVR

Job description

Contractor, Safety Systems supports the maintenance and administrative activities related to the Global Safety Systems. This role manages activities associated with the end-to-end solution (i.e. configurations, user access, reporting rules, etc.) Contractor, Safety Systems should understand drug safety as well as have a strong understanding of the limitations and capabilities of Oracle Argus safety enabling them to lead and complete assigned activities with minimal supervision.

Key Responsibilities:

Develop and Maintain Global Safety Systems (75%) Perform safety systems administrator activities, including maintaining code lists, database libraries, reporting rules, reporting destinations and data entry validations Perform onboarding/offboarding activities for all PV vendors requiring access to global safety systems, PV SharePoint sites, PV Distribution Lists, External contact lists, etc. Support and lead PV project initiatives and process improvements updates e.g. Global Safety database configuration customizations, system upgrades, etc. including maintaining key safety systems documents (Requirements, Configurations, Traceability, etc.) Work with PV Operations team to configure new studies and maintain Products and licenses in Global Safety Systems Support end users troubleshoot Global Safety Systems issues, including reporting issues to vendors via vendor ticketing tools and follow through with resolution or workaround Develop queries and reports to provide data from the Global Safety Systems to support various PV needs, e.g. Aggregate reports, Signal reports, Study reports, and ad hoc reports.

Global Safety Systems oversight activities (25%):

Develops and maintain Global Safety Systems SOPs, Work Instructions and Data entry guidelines Conducts routine Global Safety Systems maintenance activities, e.g. Dictionary updates, User access reviews, Annual Reporting rules/Product/Study reviews on timely manner in alignment with regulatory requirements Collaborates with IT to manage PV IT requests e.g. PV SharePoint sites, IT Tools, Mailboxes, etc. Participate and support PV inspections and audits Maintains and participates in PV training of junior staff, vendors, and employees on safety system responsibilities Other duties and responsibilities as assigned

Required Qualifications:

8+ years of relevant experience and Bachelors/Advanced degree preferably in life science, nursing, pharmacy, or other healthcare related profession (MD, RN, PharmD, NP, PhD, MPH, etc.). Ten plus years of relevant experience in Safety Systems (e.g. Argus, Aris Global, Veeva, Reporting tools, etc.) in capacity of maintenance, technical interface, and reporting tools (e.g. IQVIA PVQ, RxLogix PVR, etc.) Strategic thinking, planning, organizational, project management Customer Service Orientation Good understanding of pharmacovigilance including Good Vigilance Practices, Drug Safety processes, standards, conventions and governance Previous experience and formal training with safety database programs including configuration and validation activities is desired Experience with producing documentation in a regulatory-compliant (life sciences) environment Knowledge of the clinical drug development industry, procedures/processes, and regulatory standards desirable Proficiency in related, underlying technologies and experience in data querying/mining Possess excellent organizational and communication skills

Preferred Capabilities:

Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously Strong knowledge of electronic systems used to manage clinical trial data and safety reporting (i.e., eTMF, EDC, Argus, ArisG, IVRS) including electronic gateway for submissions Experience with overseeing and managing safety systems vendors’ experience is highly preferred Proficiency in related, underlying technologies and experience in data querying/mining, Argus up-versioning, Dictionary upgrades, and data migrations, strongly preferred Knowledge of other drug safety solutions/ relational databases, SQL preferred Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures