Pharmacovigilance Specialist

This is a 100% home-based role _Job Overview**Essential Functions**- 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**Qualifications**- Bachelor's Degree in life sciences- Up to 5 years of relevant experience, inclusive of up to **3 years of Pharmacovigilance experience in case processing.**- English Advanced- 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.- To demonstrate effective project management and leadership skills.- 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 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.- Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities.- Ensure quality of deliverables according to