Senior Account Manager, Platform Success
IQVIA
Operations Specialist II
IQVIA
full-time
Posted on:
Location Type: Office
Location: Dalian • 🇨🇳 China
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Process Safety data according to applicable regulations, guidelines, SOPs and project requirements
- Perform Pharmacovigilance activities including collecting/tracking incoming Adverse Events (AE)/endpoint information, determining initial/update status, database entry, coding AE and products, writing narratives, literature activities, quality review, reconciliation, case closure, coordinating translations
- Create, maintain and track cases per project plan
- Perform activities related to adjudication as applicable
- Assess Safety data for reportability and report to regulatory authorities, ethics committees, IRBs, investigators and oversight groups within timelines
- Liaise with stakeholders and manager for regulatory tracking and electronic reporting
- Contribute to or lead deliverables in Safety Publishing, Risk Management, Safety Surveillance and Medical Information
- Ensure quality, productivity and delivery standards per project
- Ensure compliance to all project related processes and activities
- Build a collaborative team environment, provide training and mentoring to junior staff, assist Operations Manager as backup
- Provide technical and process information to Safety Management and operations team
- Provide oversight on operational team status, metrics, productivity and initiatives
- Maintain understanding of project protocol, therapeutic indication, budget and scope of work; set up and maintain project files, templates, forms, databases and workflow
- Establish and maintain effective team and project communications; report metrics and out-of-scope issues
- Read and acknowledge IQVIA and customer SOPs; complete required training and maintain training transcripts
- Participate or lead trainings across Safety processes; participate in working groups for new initiatives and process efficiencies
- Demonstrate problem solving capabilities and liaise with project management, clinical, data management and health care professionals
- Attend project team meetings and liaise with clients about day-to-day activities
- May perform medical review of non-serious AEs/ADRs including AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and documentation
Requirements
- Bachelor's degree in life sciences or related field
- Up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience
- Or equivalent combination of education, training and experience
- Excellent knowledge of medical terminology
- In depth knowledge and understanding of applicable Safety Database and any other internal/Client applications
- In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements
- Excellent organizational skills, time management skills, attention to detail and accuracy
- Maintain high quality standards
- Excellent working knowledge of Microsoft Office and web-based applications
- Effective project management and leadership skills
- Effective mentoring and coaching skills
- Excellent verbal/written communication skills
- Self-motivated, flexible, receptive to changing process demands
- Willingness and aptitude to learn new skills across Safety service lines
- Proven ability to work independently and autonomously with policies and practices
- Proven ability to multi-task, meet strict deadlines, manage competing priorities
- Ability to identify, prioritize tasks and delegate to team members
- Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients
- Ability to work as a Team Player, contribute and work towards achieving Team goals
- Demonstrate sound judgment and decision making skills
- Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities
- Ensure quality of deliverables according to the agreed terms
- Support audit preparedness
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Regular sitting for extended periods of time
- May require occasional travel
- Flexibility to operate in shifts
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
PharmacovigilanceAdverse Events (AE) codingSafety Database managementMedical reviewQuality reviewCase closureRisk ManagementSafety SurveillanceData entryProject management
Soft skills
Organizational skillsTime managementAttention to detailLeadership skillsMentoring skillsVerbal communicationWritten communicationProblem solvingTeam collaborationDecision making
Certifications
Bachelor's degree in life sciences
