SGS-Group Belgium Nv - Waals Brabant
and safety of drug ingredients and the drug development process - from the early development stages until the commercialization of the finished... regular update of Working Procedures/ Guidelines for the spontaneous data handling, including training on new or updated safety procedures...
Drug Safety SOP/Training Manager
UCBPharma - Waals Brabant - Verenigde Staten
for Drug Safety and is responsible to provide high quality, efficient and timely support to all members in Drug safety, affiliates and relevant... of internal work processes, technologies and quality of deliverable generated by the Drug Safety SOP/training team and more generally by the...
Drug Safety SOP/Training Manager
UCB Pharma - Eigenbrakel, Waals Brabant
management for Drug Safety and is responsible to provide high quality, efficient and timely support to all members in Drug safety, affiliates... efficiency of internal work processes, technologies and quality of deliverable generated by the Drug Safety SOP/training team and more generally...
CVO-EUROPE GROUPE CYBERCONSEIL - Waals Brabant
In order to insure our development and to reinforce our teams, we are hiring a Drug Safety Consultant Permanent Contract or freelance... contract for Walloon-Brabant Main tasks and responsibilities Supporting Drug Safety activities by: - Screening scientific literature to identify...
INC Research - België
job ID: 8836 Position Title: Clinical Safety Associate Working Location: Belgium Regional Employment Status: Full-Time Regular... Required Experience: Not Applicable Required Education: Not Indicated Required Travel: 0 Job Summary: Encoding of spontaneously safety reported cases...
Global Pharmacovigilance Systems and Processes, Safety Project Manager
UCB Pharma - Eigenbrakel, Waals Brabant
and Pharmacovigilance (drug safety) at UCB. The main goal of this function is to develop and optimize the safety processes and safety system functionalities.../ Coordinate the implementation of Global safety systems for the management of drug safety information, tools, and procedures, and to implement...
of MedDRA and therapy dictionaries for AE and drug coding. · Gives appropriate indications to the Named Safety Contact (NSC) or affiliates in order... template and is able to integrate additional information. · Interacts with safety responsible physicians when needed. · Ensures a standard quality...
Quality Assurance Specialist GMP - Leuven region
, vascular disease, and cancer. Job description We are currently looking for a Quality Assurance Specialist GMP The candidate (m/f) will work closely... and responsibilities : • Reviewing and management of GMP related documents in order to support GMP activities at vendors (drug substance manufacture, drug...
Pfizer - Brussel
emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents * Deep... and study design feasibility for all programs / trials. RMMs are responsible for optimal site/patient selection, patient safety, site compliance...
Clinical Research Associate II, III, Senior CRA roles in Top5 CRO in Belgium
Meet Recruitment - België
, Life Sciences - Developmental Biology, Life Sciences - Drug Development & Discovery, Life Sciences - Immunology, Chemistry - Quality Control/QA..., Clinical - Programming, Clinical - Project Management, Clinical - Quality, Clinical - Regulatory Affairs, Clinical - Research, Clinical - Safety...
Johnson & Johnson Family of Companies - Beerse, Antwerpen
the Statistical Analysis plan (SAP) within the specified timelines. * Review the Data Safety Monitoring Board (DSMB) protocol. * Review... and approve protocol specific PV criteria list * Develop & agree on the Safety Management Plan (frequency, format and content of reports provided...
UCBPharma - Waals Brabant - Verenigde Staten
to reach fit-for-purpose best balance of quality/time and costs To develop proactively creative and efficient solutions for IP protection of drug... product processes. To elaborate the non-clinical formulations to supply GLP and non-GLP Safety Pharmacology, Toxicology and Pharmacokinetic...
UCBPharma - Waals Brabant - Verenigde Staten
To partner with Drug Safety, Commercial Operations, New Medicines, Global Regulatory Affairs, Clinical Development and Global Medical... regulations across UCB; - To ensure the development and execution of a risk-based global audit schedule and communication thereof to Drug Safety...
CRA II - Senior, top5 CRO, Belgium
Meet Recruitment - België
- Programming, Clinical - Project Management, Clinical - Quality, Clinical - Regulatory Affairs, Clinical - Research, Clinical - Safety, Clinical...Life Sciences - Cancer Research/Oncology, Life Sciences - Cardiology, Life Sciences - Developmental Biology, Life Sciences - Drug...
Pharmaceutical Regulatory Affairs Junior Associate
MindWorks - Brussel
) Support and back-up of Responsible Person for Wholesaling Pharmacovigilance: e.g. Support/back-up of Drug Safety Officer Professional Profile... of promotional materials Review and validation of promotional/medical activities (congresses, advisory boards) Quality Management: e.g. Complaint...
Experienced Process Chemist / Engineer - Project Leader
Johnson & Johnson Family of Companies - Beerse, Antwerpen
chemical processes are developed according to customer requirements concerning safety, environment, technology, economy and quality... deliverables, including timely delivery of batches, required quality and acceptable API characteristics. You propose and follow-up on API Development...
SGS-Group Belgium Nv - België
Services to the pharmaceutical and biopharmaceutical industry. It provides outsourcing services on both the quality and safety of drug ingredients... Affairs Management - Perform a QC check on materials developed by sales & marketing and the medical department and provide feedback on the quality...
Sr Clinical Medicine Director (GI)
Shire - Basingstoke, Hampshire - Turnhout, Antwerpen
drug safety surveillance for Development projects. * Provides credible company representation in the academic Medical/Scientific Community... authority requirements, stakeholder requirements, and quality standards are met. * Partner with other Shire functions to communicate scientifically...
Johnson & Johnson Family of Companies - Beerse, Antwerpen
material compliance * Ensuring drug product quality * Ensuring processability * Development and implementation of specifications for excipients...Material Sciences is a department of Pharmaceutical Development and Manufacturing Sciences-Drug Product Development (PDMS-DPD). The...
UCBPharma - Waals Brabant - Verenigde Staten
Proposes, develops and maintains specific operating procedures, working instructions and user guides for ensuring compliance and quality.../dynamics and population modelling methods, in orderto support the needs of the Global Pharmacometrics dept * Awareness of all phases of drug...