Job Title – PV Associate
Industry - Pharmaceuticals
Location - Amsterdam, Netherlands
Duration - 7 months
Start Date - 01/04/2020
Languages – Dutch and English
About the company
A multinational pharmaceutical company committed to developing and producing innovative and quality medicines for the patients.Job Description
Together with fellow team members, you ensure that all reports of side effects are processed on time and shared with internal colleagues (both local and global) and external parties such as partners and authorities. In addition, reconciliation with other parties is part of your work. According to Standard Operating Procedures (SOPs), work instructions and manuals.
You work in this position together with other departments including the Medicine department, the Quality Department and the Customer Service. You will find it a challenge to ensure that all internal and external directive and legislation in the field of pharmacovigilance is met.
- Daily review and processing of reports of side effects in the companies Global Safety database.
- Liaise with healthcare professionals, patients and partners to collect additional information about the notifications.
- Reconciliation of side effects with both internal departments (e.g. the Medical Department, Quality Department, Customer Service) and external partners based on Safety Data Exchange Agreements (SDEAs).
- Documenting and archiving security information in accordance with company procedures and relevant laws and regulations.
- Conducting compliance activities related to Individual Case Safety Report (ICSR) submissions.
- Assisting in audits and inspections.
- Completed round training in a medical or pharmaceutical direction (experience in pharmacovigilance/case processing is a big plus).
- Reliable and a great sense of responsibility.
- Honest and open communication.
- Good expression skills in both words and writings (Dutch and English).
- Team player, but also able to work independently and set priorities yourself.
- Accurate and well able to create an overview in complex information flows.
- Affinity with and preferably experience with databases and the ability to quickly own new systems/processes.