We are looking for the best talent, with Dutch 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.
Key responsibilities :
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.
AdverseEvents(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 C1 / C2 level Dutch and fluent in English language.
Bachelor’s Degreein 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.