Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.
Responsibilities :
Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information
Determining initial/update status of incoming events
Database entry
Coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
Perform activities related to adjudication as applicable
Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.
Liaise with manager for regulatory tracking requirements and electronic reporting.
Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
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 Safety 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.
Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects
Set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.
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 up to date training transcripts.
Participate or Lead trainings 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
100% compliance towards all people practices and processes
In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications.
Requirements :
Bachelor’s Degree Scientific or healthcare discipline or allied life sciences Req
Bachelor’s degree in life sciences or related field and up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience
Excellent knowledge of medical terminology. Intermediate
In depth knowledge and understanding of applicable Safety Database and any other internal/Client applications. Advanced
In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements. Advanced
Excellent organizational skills, time management skills, attention to detail and accuracy. Advanced
Maintain high quality standards. Advanced
Excellent working knowledge of Microsoft Office and web-based applications. Intermediate
To demonstrate effective project management and leadership skills. Intermediate
Effective mentoring and coaching skills. Advanced
Excellent verbal/written communication skills. Advanced
Self-motivated, flexible, receptive to changing process demands. Advanced
Willingness and aptitude to learn new skills across Safety service lines. Advanced
Proven ability to work independently and autonomously with policies and practices. Advanced
Proven ability to multi-task, meet strict deadlines, manage competing priorities. Advanced
Ability to identify, prioritize tasks and delegate to team members. Advanced
Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Advanced
Ability to work as a Team Player, contribute and work towards achieving Team goals. Advanced
Demonstrate Sound judgment and decision making skills. Advanced
Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities. Intermediate
Ensure quality of deliverables according to the agreed terms. Advanced
Demonstration of IQVIA core values while doing daily tasks. Advanced
Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations. Intermediate
Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders. Intermediate
Support audit preparedness Advanced
Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate
Regular sitting for extended periods of time. Intermediate
May require occasional travel. Intermediate
Flexibility to operate in shifts. Advanced