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

Qualifications

• Pharmacovigilance(PV) 업무 5년 이상 경력자 또는 임상 경력 포함 5년 이상의 경력자 (최소 PV경력 1년 이상)

• Experience in setting up and operating Safety Databases such as Argus, ArisG, and Cubesafety etc.

• Deep understanding of regulations and guidelines related to Pharmacovigilance (PV)

• Experience in planning, executing, and monitoring PV projects.

• Effective communication and collaboration skills with team members and stakeholders.

• Experience in writing safety reports and documentation.

• Degree in life sciences, pharmacy, or a related field.

• Proficiency in database management and related software.

• HA safety reporting and relevant communications with HA/Study team

• Clinical Research experience would be an advantage

• Good English communication skill is required