Pharmacovigilance Scientist

About the jobProthya Biosolutions makes life-saving plasma medicines and is proud of it! Every day, Prothya colleagues are delighted to go the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible, fast-growing company with an interesting history? As a Pharmacovigilance Scientist you are responsible for ensuring drug safety by monitoring, assessing, and reporting side effects and other drug-related problems in the organization. At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn! Are you moving along? Then apply now!Your responsibilities:1. Processing ICSRAssess validity of ICSRTriage, assess seriousness and expectednessEnter ICSR into data baseCoding of ICSR informationFollow-up to receive information required to assess causalityTimely reporting to health authoritiesPerform monthly reconciliation with third parties2. Database maintenanceEnsure operability of Prothya safety databaseClose interaction with database host/service provider to maintain technical standards and compliance with legal/regulatory requirements3. Aggregate reportingContributes to aggregate reports and create database outputs and overviews required for these reports4. Quality Management SystemCompliance with Prothya PV KPIsMaintain Pharmacovigilance SOP’s and WI’sContribute on the maintenance of RMPs and PSMF5. Safety signal managementContributes to safety signal management6. GVP complianceEnsure full legal and regulatory complianceAdhere to, and keep abreast of ICH-GVP regulationsCompliance with Prothya SOP’s and quality standardsMaintain adequate levels of training and education7. Interaction with stakeholdersConstructive collaboration with, and support of internal and external stakeholders.Collaborate with external service providers (e.g., CRO’s ) on safety management, either in the setting of post marketing safety experience, or clinical trials.Provide safety information to Prothya functions as required (e.g., Medical Affairs, Regulatory, Quality).Your profile:Bachelor degreeOpen communication and good personal interaction stylesAdaptability to change and work independentlyPerseverance and commitment to work environmentAt least 2 years of experience in pharmacovigilance environmentMedical/scientific backgroundKnowledge of case processingKnowledge of GVP regulationsAdvanced computer skills and understanding of database technologiesWhat we offer:A market-rate salaryA budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthlyA fulltime employment of 40 hours per weekFlexible working hours after deliberationYour own place in a close-knit and expert team with an employer that stimulates growth and personal developmentGood accessibility by public transport and we provide private parking;Sound pension provision.Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.