Team Lead- ICSR - Clinical Trial

About Navitas Life Sciences:

Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries.

At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider.

Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry.

Navitas Life Sciences is proud to be an HIG Portfolio company.

Website: www.navitaslifesciences.com

Responsibilities & functions: ICSR Clinical Trial

To assist in lead activities in clinical or post-marketing pharmacovigilance service lines. Apply knowledge & expertise for decision making activities on process related activities. Provide oversight on assigned operational projects and act as a mentor in the team.

All the following responsibilities and functions are undertaken in line with Navitas Life

Sciences (NLS) current Standard Operating Procedures (SOPs), Policies and ICH-GCP. The duties and responsibilities listed below are representative of the nature and level of work assigned and are not necessarily all-inclusive:

Workflow Planning:

Assign project level lead/Manager (WL/WM) to manage delivery across all workflows including, daily workflow monitoring like intake of reports, workflow allocation and tracking, prioritization, submissions, Compile EOD reports, Query followups, Reconciliations.

Schedule and lead workflow meetings with Delivery Leads/Project Managers.

Workflow reports/dashboard - Publish daily/weekly/monthly status report for projects

Monitor KPIs/CTS//SLA at project level. Drive continuous improvements including automation.

Submissions

• Manage Workflow Management & Submissions
• Ensure adequate levels of available capacity & capabilities for Workflow manager/Lead for management of Submissions
• Manage Delivery, resource utilization, people management
• Effectively manage Submission workflow in such a way that agreed delivery performance (cost, compliance, quality as per Client/Project requirements) can be maintained at all times
• Responsible for submission/distribution of reports for both expedited cases
• (SUSAR) and periodic reports to regulatory authorities, partners, sites/investigators/IRBs (if applicable)
• Planning and monitoring cases/reports requiring submissions Ensure compliance to SLA/Client/Regulatory requirements.

Provide and manage project specific trainings to the assigned team.

Participate in Workflow, Operational/any client specific or other stakeholder meetings.

Develop project specific WIs/Functional plans/Training plan for respective delivery, as per client specifications provided in SOW or by Program/Project manager.

Prepare Deviation & CAPA for respective errors and ensure preventive measure are in place.

Provide project specific performance feedback to the management and escalate issues in a timely manner.

Advising staff on administrative policies and procedures, technical problems, and prioritization

Provides oversight and guidance on organizational goals and company objectives Participate/Support in Audits and responsible for closing CAPAs on time.

Participate in designated activities to support revision/creation of case processing procedural documents

Read and acknowledge all necessary NLS and Sponsor's standard operating procedures as required.

Participation in local or global project teams, including on-time delivery of assigned responsibilities

Support on overseeing, improving, and contributing to procedures and performance

Collaborate in the development, review, and initiation of SOPs

Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects

Mentors other staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion, and integrity, support Senior Management's leadership of both the department and the company

Support oversight on operational activities and sound understanding on project plans/documents.

Participate in team meetings and provide regular feedback to the management on operational metrics and other challenges/issues.

Participate in trainings offered by NLS and sponsors and contribute to identification and implementation of process efficiencies.

Liaise with mangers and in proactively identifying issues and proposing solutions.

Providing technical reports, metrics, invoices, and support on new initiatives

Delegating client requests and ensure it is addressed within the timelines.

Contribute to achieve all SLA's agreed for both internal and external on the projects.

Executes administrative operational tasks as required Perform other duties as assigned.

Qualifications & competences:

• Life Science
• 8-10 years' experience in Pharmacovigilance
• Comprehensive medical knowledge
• Experience in the conduct of clinical trials and post-marketing PV
• Basic knowledge of medical coding (MedDRA / WHO-Drug Dictionary)
• Very good knowledge of written and spoken English
• Good knowledge of usual office software (MS Office Word, Excel, PowerPoint) Soft skills (motivation, strong communication competence, structured in work, or anisin skills, reliabilit commitment and ca acit for team-work