For one of our clients located in Brussels, we are currently looking for a Safety Data Management Specialist.
All over the world, our client is working to positively impact health for everyone, everywhere. Each position in the company touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, our client is committed to seeking out inspired new talents who share our core values and mission of making the world a healthier place.
The Drug Safety Unit is responsible for a correct and precise intake and follow-up of adverse events occurring during the use of a product.
This concerns spontaneous reports provided by health professionals and patients and also reports coming from market research and patient programs. This way, we contribute to a correct safety profile of our products.
These data are collected worldwide and used for signal detection. The results are bundled in safety reports and are made available to government, ethical committees and researchers participating to our clinical studies.
Project Description
Review, preparation, and completion of reports of adverse drug experiences of products. Work within our adverse event intake system and global safety database. Collaborate in a small team in a highly regulated environment.
Determination of local submission of individual and aggregate safety reports.
Responsibilities
- Receipt of reported adverse events and at-risk notifications. Ensure understanding and meaningfulness of the reported cases
- Verify, rank and document case-related information based on event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Prioritize cases based on these assessments
- Recognize and address particular adverse event complexities or issues, and escalate where needed
- Process the case information in the global database and write/edit the case narrative, in line with the completion instructions.
- Review case criteria to determine the appropriate workflow for case processing. Dispatch case within the correct timelines to a peer colleague for review.
- Determine and perform appropriate case follow-up, including generation of follow-up requests
- Liaise with key partners, local and other stakeholders regarding safety data collection and data reconciliation
- SUSAR distribution to investigators and Ethics Committee
- Perform local submission of aggregate safety reports
- Develop and maintain expertise and knowledge for applicable corporate and global regulations, and guidelines (e.g., GVP modules), Standard Operating Procedures and data entry conventions,
- Build expertise in pharmacovigilance and related topics like non-interventional studies, compassionate use, medical need programs and materiovigilance
- Consistently apply regulatory requirements and the policies
- Participate, as appropriate, in local, internal and external safety activities
Requirements
- Background in a (para)medical field or equivalent experience preferred
- Experience in a pharmaceutical environment is an asset
- You can work in a regulated framework
- Ability to make basic decisions with an understanding of the consequences
- Demonstrate good computer literacy
- Strong administrative skills and are able to work accurate
- Analytical though pragmatic and solution-minded
- Ability, with supervision, to solve routine problems and to surface issues constructively
- Work in team and are able to work autonomously on dedicated tasks
- Dutch or French knowledge 5/5 and fluent in spoken and written English
- Existing right to work in Europe required
