Your job
- Ensure the company's Pharmacovigilance responsibilities regarding marketed products in EU and globally are fully met and appropriate PV Quality Management Systems are utilized both internally and externally (in the case of affiliates or partners), in compliance with company’s policies & procedures as well as national & international legislation and guidelines.
- Represent Prothya PV in liaising with 3rd party PV provider and partners
- Manage timelines for responses to PV audits, inspections, and queries from all stakeholders and customers
- Work closely with the Qualified Person Responsible For Pharmacovigilance (QPPV), deputy QPPV, and other members of the pharmacovigilance team/service providers, to ensure timely, effective, and appropriate processing and evaluation of Safety Data Exchange Agreements (SDEAs), documents and reports necessary to maintain a compliant pharmacovigilance system
- Contribute to the implementation and improvement of the Quality System Element (QSE) for the PV system;
- Liaising with and providing PV guidance & advice on PV topics to all key stakeholders
- Assist in the management & oversight of PV variation changes and updates, transfer of PV information to other internal departments, PV SOP, and PV training
- Prepare/Review, maintain, and present PV Key Performance Indicators (KPI’s) to management
Your profile:
- Academic medical (scientific) training;
- 2-5 years of experience in the field of Pharmacovigilance, Regulatory Affairs or related fields of Quality; either in the pharmaceutical industry, regulatory authorities, or specialized service providers
- Knowledge of European and other international regulations in the field of Pharmacovigilance
Our offer
- We offer you a fulltime position with the following employment conditions
- A market-rate salary
- A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
- A fulltime employment of 40 hours per week
- Flexible working hours after deliberation
- Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
- Good accessibility by public transport and we provide private parking;
- Sound pension provision.
More info
If you would like to know more about this vacancy, please contact our recruitment department via careers.nl@prothya.com. Do you recognize yourself in the profile and do you want to take on this challenge at Prothya Biosolutions? Then we would like to receive your resume and motivation via the apply button on this page. We aim to respond to you within a week.
