Patient Safety Analyst
We are looking for a Master degree in a scientific area with minimum 2 years of experience in project management Pharmacovigilancy in the pharmaceutical industry.
At XPE Pharma & Science you're not just a consultant, you are one of a kind.
Not only will we track down the perfect assignment for you. Our HR Talent Managers value Talent and build client-focused solutions with that in mind. They are dedicated to help you boost your career. This by coaching sessions, development centers and performance reviews.
Respect and professionalism are at the basis of our job. We are willing to go the extra mile for and with you.
The main goal of this function is to develop Pregnancy toolkit (data extraction reports) from business point of view to ensure that PS (Patient Safety) can extract Pregnancy data with ease and reduce manual review of data.
Major aspect of this function is to gather requirements, plan, prioritize, and drive the delivery of Pregnancy data extraction reports by working with service provider to meet user community needs.
- Understand Pregnancy data extraction requirements of Patient Safety
- Establish framework and document detailed requirements for Pregnancy data extraction reports
- Liaise with external Custom Reports Service Provider to give appropriate specifications
- Lead from business point of view, meetings with reports development team and monitor development of reports
- Interacts with external Custom Reports Service Provider to ensure quality, test and validate reports
- Review of the validation documentation before approval
- Organize training for the Users
- Escalate issues and risks to Head of SSTS
- Ensure communication- status updates.
- MSc or higher preferably in life sciences or public health
- 3-5 years experience leading projects / international project management is required
- By preference at least 5 years of experience in the pharmaceutical sector, including experience in Pharmacovigilance
- Experience in case processing, functional analysis, software validation, project delivery and change management are required
- Experience in processing Pregnancy, Paediatric or Breastfeeding cases is preferred
- Detailed knowledge and experience with ARGUS / ARISg or any inhouse global safety database systems and patient safety data reporting is preferred
- Experience with safety reporting tools (BusinessObjects/Cognos) is preferred
- Demonstrated experience in leading and participating in collaborative work teams at local and global levels
- Excellent communication and interpersonal skills
- Ability to identify issues and drive for resolution
- Ability to work under pressure
- Ability to work without close supervision
- Fluent English required
- Computer proficiency, excellent skills in Microsoft Office Tools, project management tools
- International travel required (estimated 5-10% of the time).
You gain experience in a global pharmaceutical company and within a collaborative and entrepreneurial working environment where employees can be proud of the meaningful work they do!
You will receive a full time contract and a competitive salary package.