
Pharmacovigilance Assistant
Job profile
As a Pharmacovigilance Assistant at Synthon, you will support the collection, processing, and reporting of safety information for our products. You will work within a collaborative, international team to ensure compliance with global pharmacovigilance regulations (GVP, ICH, EMA, FDA) and internal quality standards.
This role is ideal for an early-career professional with a life sciences background who wishes to build a career in drug safety and regulatory compliance.
Job responsibilities
Together with your peers you will work on the following tasks:
- Support case processing by performing quality control and follow-up with relevant stakeholders.
- Assist in the quality review of Signal Management Reports, Periodic Safety Update Reports (PSURs) and other regulatory submissions.
- Maintain pharmacovigilance documentation, tracking logs, and safety databases in accordance with Good Pharmacovigilance Practices (GVP).
- Support audits and regulatory inspections.
- Collaborate closely with global affiliates, regulatory affairs, Clinical Research & Development and Toxicology, Service Providers, and other departments.
- Contribute to continuous improvement initiatives within the Pharmacovigilance function by writing/updating/review standard procedures.
- Receive, register, and process adverse event reports from healthcare professionals, consumers, and partners.
- Reporting to EMA. MHRA, and FDA.
- Perform reconciliations.
- Sporadically, perform data entry and coding of safety cases using MedDRA and internal databases.
Your profile
- An education in Pharmacy, Life Sciences, Biomedical Sciences or a related discipline.
- A strong interest in drug safety and regulatory compliance.
- An excellent command of English (written and spoken), knowledge of the Dutch language is a plus.
- And are you good in Microsoft Office (Excel, Word, Outlook).
Personal skills
You have a meticulous attention to detail and are committed to accuracy. You are good at organizing your own work and are able to work under strickt timelines when necessary. You can work independently but also love to collaborate across multiple functions. Your well-structured approach and result-oriented mindset with focus on compliance and continuous improvement makes you a trusted colleague in any project.
And yes—sharing a coffee and a conversation with you is genuinely enjoyable.
Our offer
We offer our employees a working environment in which trust, pride, and joy play an important role. We understand our economic, social and environmental impact on the wider world. We care - for each other, for partners, for patients and for society at large. We support various educational initiatives and actively contribute to charitable causes and to the development of the communities worldwide to which we belong. We offer a professional, yet pleasant and informal working environment with short communication lines, focusing on cooperation and appreciation of initiatives.
More specifically, we offer our employees:
- Good working conditions with attention to ergonomic support
- A keen eye on work/life balance, with the option to partly work from home
- A yearly outing with all colleagues and multiple inspiring company events.
The annual fulltime salary range for this position is between € 34,000 and € 46,000.
The contract hours are between 32 and 40 per week.
Application and important dates
If you are interested in this position and you would like to join our company, we look forward to your application no later than 9 November 2025.
Contact
For further information, please contact Ascanio Maia, Head of Drug Safety, at tel. +31(0)24 37 27 700
Acquisition in response to this advertisement is not appreciated.