Pharmacovigilance Scientist Amsterdam • Prothya Biosolutions

Your responsibilities:

1. Processing ICSR

• Assess validity of ICSR 
• Triage, assess seriousness and expectedness 
• Enter ICSR into data base 
• 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. Database maintenance

• Ensure operability of Prothya safety database
• Close interaction with database host/service provider to maintain technical standards and compliance with legal/regulatory requirements

3. Aggregate reporting

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

4. Quality Management System

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

5. Safety signal management

• 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 with stakeholders

• Constructive 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 degree
•  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 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.

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.