Qplus consult offers high-level quality services for pharmaceutical companies. Qplus consult built a solid and strong reputation within the pharmaceutical sector, therefore, we are looking for a motivated, dynamic and flexible Drug Safety Advisor to join our team. Who are we? With our 6 service lines (Medical Affairs, Pharmacovigilance, Quality Management, Regulatory Affairs, Auditing and Training), we are an expert in our job within the pharmaceutical industry. We emphasise our values: client first, dedication, loyalty, passion, professionalism and performance. Our main focus is to build a long-term relationship with each of our clients to provide a service of excellence in a timely and cost-efficient manner. To meet these expectations, we have a team of professional experts who are exceptionally highly trained and ready to provide excellent service every day. Check out our company story on our website and join our team! As a Drug Safety Advisor, you focus on providing high quality, comprehensive, technical and scientific information services to our customers regarding their product range. This involves supporting and enhancing the safe and effective use of products, enabling our customers to make informed decisions about their product range. You provide a first line technical and scientific information service to the internal pharmacovigilance (PV) team and customers; You handle all medical enquiries, in particular, Adverse Event Reports and pregnancy reports, in line with procedures; You take care of a medical evaluation of spontaneous adverse reactions; You contribute to and perform medical assessments of the specific documents (e.g. safety profile of medicines, detected scientific literature, signals, cases etc.; Periodic and Development Safety reports, Risk Management Plans, DHPC etc.); You report cases to EMA within defined time frames and ensure appropriate levels of follow-up with reporters to fulfil all legal and regulatory requirements; You ensure all appropriate reports are distributed to regulatory authorities, Ethics Committees and investigators within regulated timeframes; You provide pharmacovigilance expertise to Risk Management planning cross-functional teams with input to formulation, implementation, maintenance and tracking of local RMPs and PSURs; You provide a comprehensive information service to external healthcare professionals and patients on the safety of company products in the scope of Risk Minimization Measures; You undertake appropriate activities to train colleagues on obligations about AE reporting; You contribute to the PV audits and inspections as required; As a part of the PV-team, you ensure any drug safety activities are in line and comply with EU-PV-legislation and procedures. You have a Master degree in Science (e.g., Medical Doctor, Pharmacy, Chemistry, Biology, Bio-technics, Bio-science…); You have the first experience in the pharmaceutical sector (as a minimum of 1-3 years of experience); You work 5 days per week from our offices in Melsbroek (on-site); You have a good knowledge of pharmacovigilance processes and European PV-legislation; You have a minimum level of C1 or C2 in English, the knowledge of another EU language is a plus; You can work in a fast-moving working environment; You are stress-resistant and work autonomously; You are quality-oriented and meticulous in figuring out and formatting your work; You are result-oriented. Working at Qplus consult brings new challenges and opportunities every day; You will be part of a dynamic, fast-growing company with a global customer ba... Expertise, Health System, Information service, Chemistry, Maintenance, Science, Biology, Audit, Literary science, Inspection, Development, Pharmaceuticals, Planning, Risk Management, Quality Focused, Health & Safety, Medicine, Evaluation, Result Oriented, Formatting, Committees, Bioscience, Legal Regulatory, Reporting, Pharmacovigilance, Formulation, Management plans, Science, Working Environment, Stress tolerance, Pharmacy, Implementation Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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