Operations Specialist

We are seeking a highly skilled and motivated professional to fill the role of Operations Specialist. The ideal candidate will have a strong background in pharmacovigilance, excellent communication skills, and the ability to work independently.

The Operations Specialist will be responsible for reviewing, assessing, and processing safety data and information received from various sources. They will also distribute reports and data to both internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines.

Key Responsibilities:

• To prioritize and complete assigned trainings on time.
• Process Safety data according to applicable regulations, guidelines, SOPs, and project requirements.
• 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, healthcare 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 team 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.

Required Skills and Qualifications:

• 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.
• Good knowledge of medical terminology.
• Working knowledge of applicable Safety Database and any other internal/client applications.
• Knowledge of applicable global, regional, local clinical research regulatory requirements.
• Excellent attention to detail and accuracy.
• Maintain high quality standards.
• Good working knowledge of Microsoft Office and web-based applications.
• Strong organizational skills and time management skills.
• Strong verbal/written communication skills.
• Self-motivated and flexible.
• Ability to follow instructions/guidelines, utilize initiative, and work independently.
• Ability to multi-task, meet strict deadlines, manage competing priorities, and changing demands.
• Ability to delegate to less experienced team members.
• Ability to be flexible and receptive to changing process demands.
• Willingness and aptitude to learn new skills across Safety service lines.
• 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.
• Ensure quality of deliverables according to the agreed terms.
• Demonstration of IQVIA core values while doing daily tasks.