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
Numbers & Facts
Location
Boston, MA
Skills
Biologyunmatched
Clinical Data Managementunmatched
Clinical Trial Managementunmatched
Communication Skillsunmatched
Customer Support/Serviceunmatched
Data Entryunmatched
Data Migrationunmatched
Data Miningunmatched
Data Qualityunmatched
Database Administrationunmatched
Detail Orientedunmatched
Documentationunmatched
Drug Developmentunmatched
Electronic Data Capture (EDC)unmatched
Environmental Sciencesunmatched
Establish Prioritiesunmatched
Financial Reportingunmatched
Follow Throughunmatched
Healthcareunmatched
Help Deskunmatched
Identify Issuesunmatched
Management of Information Systems/Technology (MIS)unmatched
Microsoft SharePointunmatched
Multitaskingunmatched
Nursingunmatched
Onboardingunmatched
Oracleunmatched
Organizational Skillsunmatched
Pharmacovigilanceunmatched
Pharmacyunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Product Reviewsunmatched
Project/Program Managementunmatched
Registered Nurse (RN)unmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Relational Databases (RDBMS)unmatched
SQL (Structured Query Language)unmatched
Safety Processunmatched
Safety Standardsunmatched
Safety Systemsunmatched
Safety Trainingunmatched
Staff Trainingunmatched
Standard Operating Procedures (SOP)unmatched
Strategic Planningunmatched
Systems Administration/Managementunmatched
Systems Maintenanceunmatched
Team Playerunmatched
Time Managementunmatched
Traceabilityunmatched
Vendor/Supplier Managementunmatched
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