IQVIA - Submission Reviewer
Submission Reviewer
Company:- IQVIA
Location:- Mumbai, Maharashtra, India (On-site)
Full-time
Hospital & Health Care
Actively recruiting
Job Description
- Apply knowledge and expertise including complex decision-making activities to do Intake oversight activity.
- Recognized as specialist in one or more areas.
- Provide oversight on ICSR Intake service operational projects and act as mentor to junior members of staff.
- Shall be responsible of end to end ICSR Intake oversight activities.
Essential Functions
- Manage ICSR Intake Oversight activity according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
- Oversees ICSR intake activities focusing on the operational processes of ICSR receipt, acknowledgement of receipt, archiving of paper ICSR files, follow-up requests, AESI (adverse events of special interest) forms, and non-valid cases
- Perform activities related to adjudication as applicable
- Oversight of the reporting rules of configuration for compounds, marketed drugs, consumer healthcare products, devices, and vaccines to ensure proper distribution/submission to health authorities, affiliate countries, license partners/collaboration partners
- Regulatory reporting expertise in all major regions, shall oversight of ICSR submission related activities in all regions, ensuring safety database is operational.
- Promptly escalates the system outages affecting ICSR distribution/submission process.
- Is the SME during internal/partner audits and inspections.
- Contribute knowledge and expertise to or lead assigned deliverables in the field of ICSR Intake oversight or other service lines as appropriate.
- Analyzing quality deviation, identifying root causes & evaluate the CAPA effectiveness.
- Ensure to meet quality, productivity and delivery standards per project requirements.
- Ensure compliance to all project related processes and activities.
- Build a positive, collaborative team environment with Intake team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed.
- Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.
- Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
- Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes; effective feedback on project performance to junior members of team.
- Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required.
- Ensure all required training is executed in a timely fashion and documented.
- Work towards ensuring completeness of individual training plan and maintain upto date training transcripts.
- Participate in training across Safety process service offerings; participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
- To demonstrate problem solving capabilities.
- Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
- Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes.
- To liaise with client in relation to details on day to day activities as needed.
- Contribute to achievement of departmental goals
Perform other duties as assigned.
Experience-
- Bachelor's degree in life sciences or related field and upto 6 years of relevant experience, inclusive of upto 3 years of Pharmacovigilance experience; or equivalent combination of education, training and experience
Knowledge –
- Excellent knowledge of medical terminology and standard follow-up guidelines in ICSR processing
- 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
- To demonstrate 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
- Demonstration of IQVIA core values while doing daily tasks
- Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations.
- Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders.
Skills And Abilities
- Sound knowledge of Microsoft excel and Microsoft presentation. Excellent communication, interpersonal, customer service, and teamwork skills.
- Excellent organizational and problem-solving skills. Ability to work independently
- Ability to establish and maintain effective working relationships with coworkers, managers and customers
- Effective Communications Skills to aptly convey your point to the clients or Vendor.
- Strong negotiations and convincing skills to help the deviation owner to understand the issues.
- The three important P's; Proactiveness, Patience and perseverance while handling issues.
- Efficient time management and multi-tasking ability.
- Ability to Independently manage end-to-end delivery of case management activities ensuring quality deliverables on time and to customer satisfaction.
- Ability to communicate lessons learned within and outside the team; ability to provide review and expert opinion in developing, revising, and maintaining process improvement operating procedures and work instructions.
Self-motivated and flexible
- 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.
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