Patient Safety Specialist - Benefit Risk Evaluation
For our Nazareth (Belgium) location, we are currently looking for a Patient Safety Speciaist.
- You will collect the required data for the authoring of Safety documents.
- You will document, write, coordinate, review and validate periodic reports such as PBRER, RMP, ACO and other related safety documents.
- You ensure generation, consistency, and quality of safety sections in submission documents.
- You discuss the content and strategy of safety documents with important stakeholders within the Benefit/Risk Group and Global Regulatory Affairs.
- You participate on writing responses or contributions for the health authorities related safety enquiries.
- You work with a cross functional team to realize deadlines for health authority requests and submissions.
- Ensure that safety documents (e.g. periodic reports, signal evaluations, regulatory enquiries, risk management plans) are written accurately and in a timely manner to meet global compliance and regulatory requirements.
- Provide support for submission of PSUR’s
- Assist in creations of core structured benefit-risk assessments, core Risk Management Plans (RMPs), and EU RMPs.
- Supports development of risk management plans in modular format and cross-use and reference of modules in PBRER etc.
- Develops and maintains respective standards and calendars for PSURs
- Contributes to cross-functional initiatives aimed to improve pharmacovigilance capabilities related to benefit -risk management
- Supports inspection and audit activities with regards to the RM & BRE processes within Safety
- Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor
- You will be safety responsible for the project of the implementation/development/update of CDS/CSI for Omega medicines portfolio
- You have experience in writing and management of CDS/CSI
- You manage cumulative safety planning in accordance with timelines as mentioned into signal management procedure.
- Management of the literature review process and make sure that t is continuously aligned with the corresponding SOP.
- Collection, management & control of countries Literature log
- Validate periodically the literature review criteria & key words provided by the service provider.
- Work very closely with the literature review service provider to improve if needed the process in place
- Ensure the systematic and continuous quality control/check of the literature review outputs
- You hold a medical/scientific degree
- You have at least 1 year of experience in a similar position for medicinal products in an international context.
- You are analytical and details oriented.
- You are able to write safety documents.
- You have a good knowledge of PSUR & RMP.
- You demonstrate initiative and capacity to work under pressure.
- You are a true team player and demonstrate leadership within cross-functional team environment.
- You speak English fluently.