Pharmacovigilance Safety Operations Specialist
- Experience Level
We are looking for the best talent, with German/French and English language expertise to be part of a global team that partnership with a major pharmaceutical company, working with patient safety on post-market products.
Apply your knowledge and expertise, including complex decision making, to review, assess and process safety and product quality information.
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 SOPs and internal guidelines under guidance and support of senior operation team members.
To Prioritize and complete the assigned trainings on time.
Receiving, reviewing and interpretation of medical report.
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.
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.
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.
Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
100% compliance towards all people practices and processes.
Minimum Required Education and Experience
Must be Native/C2 level German/French and fluent in English language.
Bachelor’s Degree in scientific or healthcare area (preferably).
Skills and Abilities
Excellent attention to detail and accuracy.
Good knowledge of medical terminology.
Working knowledge of applicable Safety Database.
Self-motivated and flexible.
Ability to follow instructions/guidelines, utilize initiative and work independently.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.