Eumedica

Eumedica is an independent pharmaceutical company specialising in the production and distribution of niche hospital products. We aim to ensure continuity of care for patients with serious, even rare diseases. This is why our motto is Ensuring Medical Care Continuity.

The focus for our development is the following:

  • expanding our range of product leaders in the hospital market
  • specialising our logistic services in the storage and distribution of clinical trial medicines
  • research in bacterial resistance to improve antibiotic treatment


Niche market, unique expertise

Eumedica provides solutions for the logistical needs of other pharmaceutical companies, including several multinationals who call on our services for their pan-European market. With our expertise and our rapidly growing distribution network, we guarantee each of our customers the best possible service, in terms of technology, operations and people.

 

Pharmacovigilance Officer, dQPPV

EUMEDICA SA is an international reference actor in the pharmaceutical sector. We offer to pharmaceutical companies a wide range of custom-made services in various domains such as regulatory affairs, distribution and promotion of pharmaceutical products as well as tailored logistics services.
Based in Manage, we are looking for talented and dynamic profiles to complete our teams and accompany us in our development.


Pharmacovigilance Officer, dQPPV


Description of the function:

As Pharmacovigilance Officer you are responsible for all pharmacovigilance and safety activities for the products from the collection until the reporting.
You are a member of the Medical & Scientific Department and you report directly to the Senior Pharmacovigilance Specialist – EUQPPV.

Your main responsibilities are:
• Being responsible for day-to-day processing of incoming adverse event reports and, where applicable, expedited reporting to regulatory authorities and to partners within defined timeframe per local legislations and PV agreements
• Being deputy QPPV (dQPPV) and able to manage QPPV activities in absence of the QPPV
• Ensuring that all Pharmacovigilance activities are conducted in accordance with internal SOP’s, Good Vigilance Practice guidelines and regulatory requirements
• Participating in literature reviews, and where applicable, managing and reporting of literature cases
• Performing Eudravigilance’s pharmacovigilance tasks including: EVWEB ICSR/MLM download, ART-57 XEVMPD management for the products, EVDAS, signal detection
• Attending project based meetings, phone conferences, and any other safety related meetings
• Contributes to the signal detection, benefit-risk profile assessment, RMP, PSUR and aggregate reporting activities
• Review of PV agreements
• Training of Eumedica’s employee on Pharmacovigilance
• …

Your profile:

• Master’s degree in a health-related or scientific discipline (medical/biomedical sciences, pharmaceutical sciences,…)
• 2-3 years’ experience in Drug Safety / Pharmacovigilance role
• Experience in the pharmaceutical industry is an asset
• Knowledge of PV management software, MedDRA dictionary
• ICSR/XEVMPD knowledge/certification is an asset
• Work precisely as per procedures, rules and regulations
• Structured, rigorous, attached to details and deadlines
• Able to work autonomously and as a member of a cross-functional team
• Fluent in French, English (spoken and written). Dutch and German are assets
• At ease with IT tools: Ms Office

We offer:

• A full time long term contract
• A salary package matching your competence
• A very diversified job with many possibilities to develop your skills
• A dynamic, ambitious and in development environment

Working place:

Eumedica s.a., Chemin de Nauwelette 1, 7170 MANAGE - BELGIUM


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