Pharmacovigilance Specialist
Pharmacovigilance Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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
- Bachelors degree in life sciences or related field required
- At least 1 year of Pharmacovigilance experience required (case intake case processing regulatory submissions)
- Oncology experience desirable
- Advanced English proficiency / fluency required
- Good knowledge of medical terminology. Intermediate
- Working knowledge of applicable Safety Database (ARGUS APEX) and any other internal/Client applications. Intermediate
- Knowledge of applicable global regional local clinical research regulatory requirements. Intermediate
This is a home-based position. Full-Time role with IQVIA.
Keywords: Case Processing Safety Pharmacovigilance Oncology Adverse Event Reporting
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
Unclear Seniority
Employment Type
Full-Time
