Pharmacovigilance Scientist PV

Prothya Biosolutions Belgium BV; Nederland; Hybrid; EUR 52,000 - 70,000; Full time

Benefits offered by this job

Holiday allowance & year-end bonus

40 hours per week

Team-oriented environment

Public transport access & private-par

Sound pension provision

Job summary

Prothya Biosolutions Belgium BV is hiring a Pharmacovigilance Scientist in the Netherlands. The role focuses on monitoring, assessing, and reporting adverse drug reactions, ensuring GVP compliance, and maintaining safety databases.

You will collaborate with internal teams and external providers to support drug safety activities while upholding regulatory standards. The position offers a full-time schedule with opportunities to grow, learn, and contribute to safety data management, signal

Job description

Prothya 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?

Pharmacovigilance Scientist

Your responsibilities:

1. Processing ICSR

• Assess validity of ICSR
• Triage, assess seriousness and expectedness
• Coding of ICSR information
• Follow-up to receive information required to assess causality
• Timely reporting to health authorities
• Perform monthly reconciliation with third parties

2. Databasemaintenance

• Ensure operability of Prothya safety database
• Close interaction with database host/service provider to maintaintechnical standards and compliance with legal/regulatoryrequirements

3. Aggregate reporting

• Contributes to aggregate reports and create database outputs andoverviews required for these reports

4. Quality ManagementSystem

• Compliance with Prothya PV KPIs
• Maintain Pharmacovigilance SOP’s and WI’s
• Contribute on the maintenance of RMPs and PSMF

5. Safety signalmanagement

• Contributes to safety signal management

6. GVP compliance

• Ensure full legal and regulatory compliance
• Adhere to, and keep abreast of ICH-GVP regulations
• Compliance with Prothya SOP’s and quality standards
• Maintain adequate levels of training and education

7. Interaction withstakeholders

• Constructive collaboration with, and support of internal andexternal stakeholders.
• Collaborate with external service providers (e.g., CRO’s ) on safetymanagement, either in the setting of post marketing safetyexperience, or clinical trials.
• Provide safety information to Prothya functions as required (e.g.,Medical Affairs, Regulatory, Quality).

Your profile:

• Bachelor degree (pharmacology, biomedical sciences, biology, biochemistry, or toxicology.)
• Open communication and good personal interaction styles
• Adaptability to change and work independently
• Perseverance and commitment to work environment
• At least 2 years of experience in pharmacovigilance environment
• Medical/scientific background
• Knowledge of case processing
• Knowledge of GVP regulations
• Advanced computer skills and understanding of database technologies

What we offer:

• 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
• 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.