Assoc Operations Specialist

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
Bachelors 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
Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate
Knowledge of applicable global regional local clinical research regulatory requirements. Intermediate
Excellent attention to detail and accuracy. Intermediate
maintain high quality standards. Intermediate
Good working knowledge of Microsoft Office and web-based applications. 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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