Bilingual Operations Specialist 1 (Portuguese*English)

Provides data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities.
Triages, tracks, and processes safety data; assesses safety data for report-ability to the client safety department or relevant regulatory bodies; maintains communication (phone, fax, email) with investigative sites or marketed product reporters to obtain accurate data regarding safety events; and contributes to lifecycle safety deliverables.

Essential Functions
Implement and support operational decisions as determined and instructed by senior management. May contribute and assist in global initiatives e.g. Change Management
Subject Matter Expert (SME) Committees
SOP Review Committees
Retention, Engagement, training, processes etc.
Assist in the implementation for measuring and improving employee engagement local and/or global actions. Maintain open and regular communication with direct reports to ensure a supportive working environment.
Supervise Safety Operations staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work
performance appraisal and professional development guidance
rewarding and disciplining employees
addressing employee relations issues
resolving problems and absence management. Approve actions on human resources matters.
Support the management on project resource assignments, staff hiring and staff terminations in collaborations with operations specialist managers. - Assists with staff training
professional and career development.
Work closely with operations managers to address problem areas, work scheduling for current and projected projects, and projected peak workloads. Monitor, assess and report utilization of staff. Identify and implement solutions to address poor utilization.
Ensure direct reports are cross trained on Safety service offering as applicable
monitor and develop training plans
identify training and development needs of staff in collaboration with Training team and Safety Management.
Lead and encourage direct reports in continuous improvement of department work processes, procedures and infrastructure. Instruct and lead direct reports in efficient management of project budgets through effective timesheet reporting. Work closely with operations specialist managers.
Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity targets. Assist with meeting department utilization and realization targets.
Ensure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, work instructions and client expectations.
Ensure that staff have been trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Work Instructions and project instructions.
Work with Safety Management constructively in a matrix framework to achieve project and customer deliverables.
Perform other duties as assigned.
Support or Lead change management initiatives
Effectively able to manage People issues
Responsible for ensuring 100% compliance towards people practice and processes

Experience Details
Bachelor's degree in life sciences or related field and up to 6 years of relevant experience, inclusive of up to 4 years of PV experience and up to 2 years of people management experience.
r equivalent combination of education, training and experience.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.