At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

The pharmaceutical company EG is a Belgian company and leader of generic medicines in Belgium. Today, the company counts 190 collaborators. EG is part of STADA Group and consists of 3 divisions: EG Generics, Consumer Care & Specialty Care. With over 30 years of experience, EG is the indisputable market leader of generic medicines in Belgium. The EG Generics portfolio contains almost 700 medicines (mostly prescription medicines) destined for the treatment of health problems in almost every therapeutic domain. The EG team also offers continuous practical support to doctors and specialists for a responsible and affordable patient care. EG Consumer Care creates innovative brands of nutritional supplements, medical aids and medicines that are available in pharmacies without prescription (OTC). We emphasize ‘evidence-based nutraceuticals’: nutritional supplements that are scientifically tested and who help you sustain your health. EG Specialty Care also offers very specialized prescription medicines – mainly to hospitals and psychiatric institutions. We are also working on expanding the product line with, among others, biosimilars. To strengthen our team, we’re looking for a: 
 

Drug safety officer   

Strombeek Bever | Belgium (BE) | Full-time | Permanent 

About EG

EG is the largest pharmaceutical company in Belgium.

With an offering for just about every therapeutic area, we are the market leader in generic medicines and the biggest OTC company in Belgian pharmacies.

We still produce many of our medicines and food supplements in Belgium. We currently have 180 employees and continue to invest in:

• The development of generic medicines to keep qualitative healthcare affordable
• Scientifically proven food supplements and medical devices that you can buy without a prescription in your pharmacy
• The development of highly specialized medicines and biosimilars

 Our culture is characterized by the strong commitment of our employees. Internally, we are called “MEP’s”: Motivation – Energy – Passion are therefore qualities that we look for in every potential new employee to help strengthen our culture.

Do you have a strong MEP level? Are you entrepreneurial and would you like to work for the largest and fast-growing pharmaceutical company in Belgium? Then EG might be the perfect employer for you.

About the Department Pharmaceutical Affairs

Pharmaceutical Affairs (PA) Department consists of Regulatory Affairs, Quality Assurance, Medical Affairs and Pharmacovigilance. The department ensures that our products are produced and delivered to customers according to the highest quality and safety standards and complying with the local and EU regulatory requirements.

About your role

The Drug Safety Officer (DSO) supports the maintenance and continuous improvements in the Local Pharmacovigilance System to ensure operations and processes are in full compliance with Good Pharmacovigilance Practices (GVP) and local regulatory requirements.

The DSO will collaborate with internal departments (Business Development, Sales, Marketing … ) and external partners (IQVIA,… ) to ensure safety of the products on the market.

This role is part of the Medical Affairs team which consists of 1 Medical Affairs Advisor and 1 Medical Affairs Specialist and reports to the Medical Affairs Manager. Since the DSO will be LPO Deputy all tasks will be performed in close collaboration with LPO (Pharmaceutical Affairs Director).

Responsibilities

• Pharmacovigilance Management: Acting as Deputy Local Pharmacovigilance Officer, you will oversee and manage all aspects of pharmacovigilance, materiovigilance, and nutrivigilance, including maintaining local PSMF files and fostering collaboration with internal and external partners.
• Adverse Event Reporting & Processing: You will be responsible for the complete lifecycle of adverse event reports, from receiving and processing them in our pharmacovigilance database to follow-up, communication and reporting to authorities, STADA and external partners. This includes providing medically sound responses to inquiries and ensuring the functionality of reporting platforms.
• Regulatory Documentation & Compliance: Prepare and submit essential regulatory documents such as Periodic Safety Update Reports (PSURs) and Addendum to Clinical Overviews (AdCOs). You will also manage and ensure compliance with pharmacovigilance contracts and participate in internal and external audits.
• Signal Detection & Risk Management: Conduct thorough literature reviews, perform signal detection, and evaluate product-specific documentation in response to regulatory decisions (e.g., PRAC, CMDh, EMA). You will also be involved in the follow-up and implementation of safety variations and the coordination of Risk Management Plans (RMPs) and Risk Minimisation Activities (RMAs).
• Medical Affairs Support: Provide essential medical and scientific assistance to internal and external stakeholders, handle medical inquiries, and contribute to the Medical Affairs strategy by offering medical insights and interpreting scientific data.
• Quality Systems & Training: Develop, maintain, and update pharmacovigilance procedures and work instructions in line with STADA guidelines. You will also organize and supervise internal and external pharmacovigilance training sessions.
• Regulatory Intelligence: Proactively monitor and stay informed about evolving legislation and guidelines in pharmacovigilance, materiovigilance, and nutrivigilance, sharing this critical knowledge with colleagues to ensure efficient application of regulations.

Required profile

• Degree of Bachelor, Higher education or Master in a scientific or (bio-)medical education (e.g. Pharmaceutical Sciences/Pharmacist, Bio-medical sciences, Drug Development or equivalent)
• Relevant work experience: 1-2 years of experience in Pharmacovigilance
• You're open-minded, collaborative, team player, ready to adapt to the changing needs
• You’re curious about new techniques and tools, and eager to always keep learning
• You have good organizational and planning skills
• Knowledge of pharmaceutical terminology is a plus
• You are fluent in Dutch, French and English
• We hire for attitude
• We expect from our employees to be Motivated, Energetic and Passioned (MEP) by their job
• You act in line with our values: Integrity, Entrepreneurship, Agility and One EG

Do you have the Motivation, Energy and Passion it takes? Then this job might be for you. Apply now!