Job Title

Project Role: Operations Specialist 1Work Experience: 3 to 5 YearsWork location: KolkataWork Mode: office basedMust Have Skills: LSMV and ArisGJob Overview:Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.Job Responsibility:- To Prioritize and complete the assigned trainings on time. - 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 - Ensure to meet quality standards per project requirements. - Ensure to meet productivity and delivery standards per project requirements. - To ensure compliance to all project related processes and activities. - 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 your individual training plan and training transcript are reconcilable. - Creating, maintaining and tracking cases as applicable to the project plan. - Identify quality problems, if any, and bring them to the attention of a senior team member. - 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. - May liaise with client in relation to details on day to day case processing activities. - To mentor new teams members, if assigned by the Manager. - Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes. - Perform other duties as assigned. - Lead/ Support department Initiatives - 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/ listed ness, 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.Educational Qualification:- Bachelor's Degree Scientific or healthcare discipline or allied life sciences Req - Bachelor’s degree and up to 3 year’s experience or the equivalent combination of experience, training and education Req