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Drug safety scientist with project management capabilities - Belgium  

Company managed [?] Still accepting applications
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Posted on : 07 June 2017

Project Description


Main tasks
  • Consistently apply and adhere to regulatory requirements and company policies to maintain pharmacovigilance system compliance. Undertaking projects, as assigned, in support of KBP business goals and objectives. 
  • Collaborating with other DSPV collaborators in order to develop and maintain in-depth knowledge on specific safety information and corresponding disease and relevant study/program expertise via the department continuous training plan.
  • Participate in DSPV department and project status meetings and reports status to management as needed.
  • Working with the DSPV team for development / maintenance of the department business processes including standard operation processes (SOPs), working instructions (WINs), agreements and sponsor- specific data.
  • Assists with generation/creation of presentation/training materials, as applicable.
  • Liaising with key partners, locally, and other stakeholders including sponsors / clients regarding safety data collection and data reconciliation
  • Maintaining interface with other KBP departments including Regulatory affairs, Quality Assurance, innovation and IT departments 
  • Liaison with KBP Business development collaborators during handling new projects / proposals providing the needed input. 
  • Full orientation with the DSPV handled projects’ duties and the relevant operational activities, representing the sponsors during inspection for the tackled duties on their behalf.
  • Monitoring and evaluation of the risks associated with the use of the sponsors’ products in pre- and post-marketing phases. 
  • Reviewing case criteria to determine the appropriate workflow for case processing. Responsible for identifying, reporting and following up on adverse events, dealing with case process backlog and responding to authorities queries. 
  • Ensures current conventions are followed upon entering cases into the Safety database and narratives writing for assigned studies as applicable
  • Supporting ICSR management business processes including: Serious Adverse Event (SAE) reconciliation, Pharmacovigilance/Safety Data Exchange Agreement review and implementation and performing Blind Breaks.
  • Receipt of individual case safety reports and assessment of criteria to determine regulatory reporting requirements, ensuring adherence to regulatory requirements 
  • Coordinating safety data collection, review, case narratives writing, processing , reportingand archiving. Determine and perform appropriate case follow-up, generating follow-up letters.
  • Experience with preparation of investigational and post-marketing regulatory reports, including aggregate safety reports
  • Manage Safety data and aggregate reports in cooperation with DSPV collaborators, ensuring accurate timely completion with reporting of periodic and expedited safety reports, in compliance with sponsor signed agreements and regulatory authorities’ timeframes.
  • Generation and Quality control of line listings and Safety data reconciliation 
  • Coordinating / Participating in DSPV department’s activities and assisting with audit and regulatory authorities’ inspection readiness readiness.
  • Identification and recording of non-conformities and liaising with Quality Assurance department. 
  • Representing KBP at internal and external meetings / conferences, communicating KBP accountabilities, deliverables and achievements as appropriate.
  • Review, rank, verifies, process and document product complaint information’s reportability  



Requirements / Competency skills
  • Develop and maintain expertise and knowledge for applicable corporate and global regulations guidelines [Eu (GVP / GCP / ICH) / non-EU (example: FDA / MENA)]. Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
  • Ability to work independently across multiple projects and work collaboratively with other team members. Investigatory nature and desire for development
  • Good Organisation skills (Entrepreneurship), proactivity and autonomy. 
  • Excellent computer literacy Proficiency in standard desktop software programs including Microsoft Office tools. 
  • Eye for detail (Meticulousness) and good interpersonal skills.  
  

Language skills
  • Fluent in reading, understanding, speaking and written English
  • Other languages are plus point.  
  

Education
  • BS/BA in life science (Biomedical / Pharmacological sciences) 
  • Degree in Nursing, Drug Safety or Pharmacy with well-developed experience in Pharmacovigilance / Drug Safety is accepted as well.
  • Industry experience in clinical development is highly desirable.  
  

Work experience
  • Solid understanding of / experience in pharmacovigilance in pre- / post-authorisation product life cycle either in pharmaceuticals, Clinical research organizations or health authorities
  • Professional experience in dealing with PV tools including safety databases, Coding tools (MedDRA / WHODD) and sharepoints.
  • project management and team leading capability.
  • Oversee day-to-day operation / team building activities / coaching project team
  • Monitor team performance and report on metrics
  • Setting clear team goals
  • Managing project delegating tasks and set deadlines / meeting due dates
  • Recognize high performance and resolve any issues or conflicts  



What we offer
You will receive: 
  • A competitive based salary commensurate with experience
  • An attractive package of extra legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
  • Commissions and Bonus Plan, with stretch targets, and the potential to significantly exceed base salary through the meeting of targets and objectives.   
  • Each employee will be welcomed with a varied integration program. 
  • We invest considerable time and resources in training our staff (technical and non-technical courses). 
  • You will join a dynamic and international environment with enthusiastic and professional colleagues. 



What we offer 
  • You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).  
  • Each employee will be welcomed with a varied integration program.  
  • We invest considerable time and resources in training our staff (technical and non-technical courses).  
  • You will join a dynamic and international environment with enthusiastic and professional colleagues.  

 
 
Who We are
  • Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.  
  • Our ‘human’ approach to service provision is what differentiates us from our competitors. 
  • Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.  
  • We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better 
  • From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.