Operations Specialist 1

Job 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.
Essential Functions
- 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
- database entry
- coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
- 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/ 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.
**Qualifications**:
- High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req
- Bachelor's degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience. Req
- or equivalent combination of education, training and experience. Pref
- Good knowledge of medical terminology. Intermediate
- Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate
- Excellent attention to detail and accuracy. Intermediate
- maintain high quality standards. Intermediate
- Strong organizational skills and time management skills. Intermediate
- Strong verbal/written communication skills. Intermediate
- Self-motivated and flexible. Intermediate
- Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate
- Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands. Intermediate
- Ability to delegate to less experienced team members. Intermediate
- Ability to be flexible and receptive to changing process demands. Intermediate
- Willingness and aptitude to learn new skills across Safety service lines. Intermediate
- Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate
- Ability to work as a Team Player, contribute and work towards achieving Team goals. Intermediate
- Ensure quality of deliverables according to the agreed terms. Intermediate
- Demonstration of IQVIA core values while doing daily tasks 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. Intermediate

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