Pharmacovigilance Operations Specialist

Job Description Summary

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

• 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 hybrid work setup and flexible shifts. Intermediate