Regulatory Affairs Specialist
il y a 2 semaines
Regulatory Affairs Engineer - Drug & Product Safety Operations About the Role We are seeking a dedicated and meticulous Regulatory Affairs Engineer to join our Research & Development (R&D) team, specifically focusing on Drug & Product Safety Operations. In this crucial role, you will be instrumental in managing, organizing, and reporting safety data related to our clinical study and post-marketing drugs and products, ensuring strict compliance with global regulatory standards. Key Responsibilities As a Regulatory Affairs Engineer, your primary focus will be on the handling and reporting of adverse event data: Adverse Event Management: Organize and compile data and narratives concerning adverse events, focusing on both short and long-term effects of drugs and products. Safety Assessment: Review regulatory reporting requirements and prepare a preliminary assessment of adverse event seriousness, causality, and expectedness/listedness in strict accordance with regulatory guidelines and product labeling. Database Entry & Maintenance: Input adverse event codes into the appropriate safety database. Maintain comprehensive adverse event files and tracking systems. Regulatory Reporting: Assist with the preparation of adverse event reports for timely submission to regulatory agencies, ensuring adherence to required reporting timeframes. Data Compilation: Compile and organize information on possible adverse events obtained from healthcare professionals and consumers. Gather and arrange cumulative safety data for submission to regulatory agencies. Documentation: Document details of potential adverse events that do not meet the criteria for formal database entry. Required Qualifications & Experience Education: University/Bachelor's Degree or Equivalent is required. Experience: Generally requires 2–4 years of relevant work experience, preferably within Drug & Product Safety Operations or a related Regulatory Affairs function. Skills: Strong organizational skills, meticulous attention to detail, and a thorough understanding of pharmacovigilance concepts and regulatory reporting requirements. Work Environment & Access Job Function: R&D Job Subfunction: Drug & Product Safety Operations Site Access: This is primarily an Off-Site role with Limited Site Access (maximum of 20 days on-site). Job Offer As a consultant through Randstad Professionals, you'll find yourself in a dynamic and challenging environment with the security of a permanent contract and an attractive salary package. Your benefits as a Randstad Professional Consultant: Salary package: Competitive gross salary, depending on your expertise and personal situation. Net compensation: An additional net compensation of €80 per month, on top of your net salary. Mobility: The option of a company car (under certain conditions) with a fuel card (also for personal use) or an attractive mileage allowance. Meal vouchers: Meal vouchers worth €140 per 20 days worked. Benefits: Annual eco-vouchers of €250. Vacation: Statutory holiday allowance, 13th-month salary, and 12 additional vacation days per year (ADV). Insurance: Comprehensive hospitalization insurance with DKV and pension savings. Growth & Development: Access to a wide range of training courses, fun activities, and career development opportunities to guide and boost your career.
-
Regulatory Affairs Specialist
il y a 2 semaines
Beerse, Belgique Randstad Belgium Temps pleinRegulatory Affairs Engineer - Drug & Product Safety OperationsAbout the RoleWe are seeking a dedicated and meticulous Regulatory Affairs Engineer to join our Research & Development (R&D) team, specifically focusing on Drug & Product Safety Operations. In this crucial role, you will be instrumental in managing, organizing, and reporting safety data related to...
-
Regulatory Affairs Senior Associate
il y a 5 heures
Beerse, Belgique Johnson & Johnson Family of Companies Temps pleinJanssen Research & Development, L.L.C., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Associate, Global Regulatory Affairs. The position will focus on drug products and will be based at one of the following sites: United States: New Jersey - Titusville, Raritan, and other J&J locations on the East Coast; other locations...
-
Medical Therapeutic Area Lead Id&v
il y a 2 semaines
Beerse, Belgique Johnson & Johnson Family of Companies Temps pleinThe Medical Therapeutic Area Lead (MTAL) is the medical leader within the assigned therapeutic area (TA) and leads the TA’s Medical Affairs team, acts as the proactive strategic partner within the Cluster Value Team (CVT) for medical excellence, and acts as a liaison between the Benelux and the EMEA Medical Affairs organization in building the CVT’s...
-
Associate Director, Global Labeling Product Leader
il y a 5 heures
Beerse, Belgique Johnson & Johnson Temps plein**Job Function**: Regulatory Affairs Group **Job Sub Function**: Regulatory Affairs **Job Category**: Professional **All Job Posting Locations**: Beerse, Antwerp, Belgium About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams...
-
Global Labeling Manager
il y a 2 semaines
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Global Labeling Manager in Titusville, NJ, Raritan, NJ or Spring House, PA, Toronto, Ontario (CA), UK (High Wycombe), Netherlands (Leiden), Belgium (Beerse), or Switzerland (Allschwil, Bern, Zug). Our company thrives on diverse company culture,...
-
Director Market Access Analytics
il y a 5 heures
Beerse, Belgique Johnson & Johnson Temps pleinWe are looking for a Director Market Access Analytics and Real-World Evidence and (MAA & RWE). Responsible for the implementation of MAA & RWE strategies to meet the needs of increasingly evidence driven and cost-conscious HTA agencies around the world. The Director provides functionally robust evidence to inform and complement that generated across...
-
Medical Science Liaison Oncology
il y a 2 semaines
Beerse, Belgique WhatJobs Temps pleinMedical Science Liaison Oncology at Johnson & Johnson Innovative Medicine Join to apply for the Medical Science Liaison Oncology role at Johnson & Johnson Innovative Medicine Job Description Working with Johnson & Johnson can change everything. Including YOU! In this exciting role as Medical Science Liaison (MSL) Oncology within our Medical Affairs (MAF)...
-
Program Manager, Investigator and Patient
il y a 2 semaines
Beerse, Belgique Johnson & Johnson Family of Companies Temps pleinJanssen Pharmaceuticals, a member of Johnson and Johnson's Family of Companies, is recruiting for a Program Manager, Investigator and Patient Engagement to join the Global Clinical Development Operations and the Investigator and Patient Engagement team. This position can be located in High Wycombe, United Kingdom; Beerse, Belgium; Leiden, Netherlands with...
-
Associate Director, Clinical Supply Integrator
il y a 7 jours
Beerse, Belgique Janssen Pharmaceuticals Temps pleinJanssen Research & Development, LLC., a member of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Clinical Supply Integrator! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and...
-
Msl Hematology
il y a 2 semaines
Beerse, Belgique Johnson & Johnson Temps plein**Working with Johnson & Johnson can change everything. Including YOU!** In this exciting role as Medical Science Liaison (MSL) Hematology within our Medical Affairs (MAF) Benelux team you are responsible for providing fair balanced, objective, scientific information and education to health care professionals and to your colleagues as required by scientific...
