Introduction
ARSANNE Consulting is looking for a Benelux RA, QA and Vigilance Manager for the BENELUX affiliate of an entrepreneurial international pharmaceutical group. Knowledge of BENELUX pharmaceutical regulatory environment is an important asset.
Your Mission
- You report directly to the General Management and you are responsible for Benelux.
- You’ll be in charge of the introduction and management of new and existing brands manufactured by the group within the BENELUX market.
Your Duties and Responsibilities :
- Responsible Pharmacist assume the function in relation to GDP (article 12ter of the medicines law of 25 March 1964) as described into Royal Decree of 14 December 2006.
- Acts as the local person for medical device distributor in accordance with the legislation of March 18th, 1999.
- Notified as the contact person for quality defects/falsified medicines at AFMPS/FAGG.
- Assumes the role as local contact person for pharmacovigilance as described into RD 14 December 2006.
- Assumes the role as RIP in relation to publicity and medical information as described into RD 7 April 1995.
- Local Regulatory Contact Person for Marketing Authorizations.
- Evaluates and approve external consultants.
- Evaluates market access dossier preparation, attend pre-meetings at FOD Economy and/or INAMI/RIZIV where appropriate.
- Evaluates & Approval of reworks on medicines.
- Provides quality & safety training to medical representatives Benelux personnel.
- Manages R&D budget.
- Reviews and approves PUB material for use.
- Maintains the box platform.
Required knowledge and Skills
Minimum requirements:
- Pharmaceutical degree
- Knowledge of GDP on medicines and/or medical devices
- Knowledge of medical information and publicity guidelines
Desirable requirements:
- Knowledge of French, Dutch and English language
- MS Office
Contacts
- Internal: International, affiliates & Benelux Corporate, local medical representatives, physicians.
- External: Local Inspections, Local Health Authorities, SPF/FOD, consultants, local distributor, and all related stakeholders & partners
Interested?
You can simply apply by clicking the Apply Now button.
