Support in Regulatory Affairs Animal Health

il y a 2 jours

HeistopdenBerg, Belgique Jefferson Wells Temps plein

Location:
**Heist-Op-den-Berg**
- Type:
**Contracting**

**#20338**

**Support in Regulatory Affairs Animal Health**

Will you be our new ambassador?

**Jefferson Wells Life Sciences** specializes in supporting **pharma & biotech companies** in their daily challenges. Hence our interest in **experts** like you to pass our team.

Let's look together at your first challenge with us

**Scope of work**:

- **General RA tasks**
- Participating in general RA meetings to be aware of RA activities on the one hand and to bring forward relevant RA topics on the other hand.
- Taking care of the general RA inbox in Outlook.
- Taking care of the general PV inbox in Outlook.
- Scanning and sending documents.
- Archiving of documents (on paper and/or electronically)
- Digitalizing of paper dossiers of products.
- **Regulatory Procedures**:
You will support the life cycle management of Veterinary Medicinal Products (VMPs) of AH. This concerns the following tasks:

- Supporting the RAM in case of RA product procedures.
- Controlling excel files with information on RA procedures or products.
- Entering and checking of RA information on products on request of the RAM.
- **Packaging tasks**:
The contractor supports the RAMs in keeping the leaflets and packaging materials of certain groups of products up to date. This involves working with the company’s packaging database and involves the following tasks:

- Starting new packaging items (package leaflet, label and box) on request of the RAM
- Changing existing packaging items on request of the RAM.
- Reviewing if the packaging is correct
- Controlling excel files with information on packaging items.
- **Repertorium and E-compendium**

You will be responsible for keeping up-to-date the RA texts of VMPs in e.g. the Repertorium (the Netherlands) and the E-compendium (Belgium). This involves the following tasks:

- Checking the VMP texts in the Repertorium and the E-compendium on request of the RAM
- Uploading new VMP texts in the Repertorium and the E-compendium on request of the RAM
- Changing VMP texts in the Repertorium and the E-compendium on request of the RAM

These tasks are administrative tasks and involve collaboration with the relevant RAM and Quality Assurance (QA) departments, as well as contact with the national authorities.
- **Pharmacovigilance**:
The contractor is responsible for entering and following Product Quality Complaints (PQCs) and supports the Sr. Pharmacovigilance Managers (PVM) with Adverse Events (AEs).
- **Finance**:
The contractor supports the RA Unit by taking care of invoices from national authorities for RA topics. These tasks involve collaboration with the RAMs and Associate,as well as contact with the national authorities (aCBG-BD and FAGG).
**Profile**:

- Secondary or Higher Education in the Life Science field (secretaries, agricultural, laboratorial, etc.)
- Knowledge and experience in the area of RA, preferably of veterinary medicines
- Stress resistant and firm
- Result driven
- Compliance and quality driven
- An accurate and systematical way of working
- Pragmatic and flexible
- Excellent speaking and writing capabilities of the Dutch and English language notion of French and German is a plus

**What can Jefferson Wells do for you?**

As an ambassador you have the opportunity to grow within international companies where you can build a **strong network**. Through a personal **follow-up**, you receive **quality support** in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal **training** and **education**.

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