Medical & Compliance Officer
Il y a 3 mois
At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years, we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
**Location: Belgium (B**russels)**
**Principal Responsibilities**
**1. Pharmacovigilance (territories Belgium, Luxembourg & Netherlands)**
- Support LRPPV in his/her activities
- Act as back-up LRPPV in absence of LRPPV
- Collection of ICSR, transfer to HQ PV department in agreed timeframes, and archiving of PV cases
- Management of local PV case database
- Local PV reconciliation of MIE and CRM
**2. Medical Affairs (territories Belgium, Luxembourg & Netherlands)**
- Support Medical Affairs Manager in his/her activities
- Manage administration of HCP literature requests, scientific support for sales force..
- Administrative support for speaker fees, consultants
- Filling of medical information enquiries
**3. Scientific information - Compliance (territories Belgium & Luxembourg)**
- Check compliance with MDeon regulations and deontological code of pharma.be of sponsor requests, expense notes
- Management and yearly submission of Transfer of Value file on betransparant platform
- Administrative management of validation of promotional material
- Administrative management of sample requests
**4. Regulatory Affairs (territories Belgium & Luxembourg)**
- Support RA manager in his/her activities
- Local RA contact for medical devices
**5. Quality Affairs (territories Belgium & Luxembourg)**
- Support QA manager in his/her activities
- Management of individual quality complaints with regards to medicine and medical devices
**Good Distribution Practice and Good Pharmacovigilance Practice**
- Respect the guidelines, quality system and applicable SOPs
- Respect the guidelines, pharmacovigilance system and applicable SOPs
**Main Requirements**
- Graduate or Bachelor in Legal-administrative support
- Proven expertise in substantive compliance-related matters including, but not limited to healthcare compliance.
- Expert knowledge of Industry Code requirements (EU and country specific)
- Good knowledge of Word, Excel, PowerPoint, Outlook
- Excellent knowledge of Dutch, French and English. Spoken as well as written.
- Strong stakeholder management and communication skills
- Able to work independently
**Relationship with Others**:
Reports to Medical Affairs Manager Benelux & UKWorks closely with HQ Quality Department, Commercial Operations, Finance, Supply Chain team.
**Disclaimer**:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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