Our Client is a pharmaceutical group, founded in 1992. Ever since they have known a steady growth. Seen their substantial growth rate, they achieved an exceptional good performance within the pharmaceutical industry. They are internationally active, yet still a family-owned business. This background results in in a very nice internal culture. They have developed a complete series of products divided into four franchises: progesterone, contraception, infectiology and supplementation. It is their ambition to provide, towards gynecologists and other medical care takers, solutions that improve the care of their patients. Our client has professional teams specialized in research and development, obtaining AMM (Market Authorization), pharmacovigilance, therapeutic information, conducting clinical trials, quality assurance, training of medical representatives.
We have an exciting opportunity for a talented and experienced ‘Benelux RA, QA and Vigilance Manager’ to join our client. It is a sole role where on one hand a lot of challenge is present besides a lot of autonomy and opportunities. The focus will lay on the Belgium region.
Key challenge is to well coordinate and organize your work, seen the combination of three main responsibilities within the role.
Responsibilities & Accountabilities
The QA, RA & Vigilance Manager is responsible for the QA, RA and pharmacovigilance for the region.
You will be supported by an external team, e.g. on market access.
You will report to the Managing Director for the Benelux and in matrix to the Group Pharmacovigilance Director. Being a core member of the team, you will add value through finding solutions and ensuring compliant work.
- You are the responsible Pharmacist, as assumed in the function in relation to GDP (article 12ter of the medicines law of 25 March 1964) as described into RD 14 December 2006.
- You act as the local person for medical device distributor in accordance with the legislation of March 18th
- You are notified as the contact person for quality defects/falsified medicines at FAGG.
- You assume the role as local contact person for pharmacovigilance as described into RD 14 December 2006 for the client and some related companies
- You assume the role as RIP in relation to publicity and medical information as described into RD 7 April 1995 for the client and some related companies
- You are the local Regulatory Contact Person for Marketing Authorizations for the client and some related companies
- You will evaluate and approve external consultants.
- You will evaluate market access dossier preparation, attend pre-meetings at FOD Economy and/or RIZIV/INAMI where appropriate.
- You will evaluate & approve of reworks on medicines.
- You will provide quality & safety training to medical representatives and clients Benelux staff
- You will manage R&D budget.
- You will review and approve PUB material for use.
- You maintain the box platform for the client.
- You will be in contact with a lot of internal and external stakeholders, such as local inspections, Local Health Authorities, FOD, consultants, but also you international colleagues as your Belgian colleagues.
Experience, Skills and Knowledge
- Pharmaceutical degree;
- Knowledge of GDP on medicines and/or medical devices;
- Knowledge of medical information and publicity guidelines;
- Working knowledge of regulatory and compliance requirements;
- Excellent knowledge of Dutch/English and a good level of conversational French;
- Earlier pharma (related) experience is required;
- You are analytic and well organized;
- You easily build long term relationships and gain confidence;
- You are open minded and solution driven;
- You have a pro active attitude, self starter.
Our client Core Values
- Integrity (always doing the right thing),
We are looking for a QA, RA and Vigilance Manager to join our client’s small but very engaged team. You will be the expert and also the manager who well organizes all QA, RA and vigilance related matters. You will be in contact with you international colleagues often and have intense contacts with your external service provider. You are the ‘face’ for all internal and external relations regarding the above and will help the business to perform in a compliant and solutions driven way. The working environment is very pleasant, and our clients looks for a team member that perfectly fits this environment.