Medical & Compliance Officer
Guerbet
Medical & Compliance Officer M/F (29222)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.For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, Twitter, Instagram and YoutubeLocation: Belgium (Brussels)Principal Responsibilities1. 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 CRM2. 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 enquiries3. 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 requests4. Regulatory Affairs (territories Belgium & Luxembourg)– Support RA manager in his/her activities
– Local RA contact for medical devices5. Quality Affairs (territories Belgium & Luxembourg)– Support QA manager in his/her activities
– Management of individual quality complaints with regards to medicine and medical devicesGood Distribution Practice and Good Pharmacovigilance Practice– Respect the guidelines, quality system and applicable SOPs
– Respect the guidelines, pharmacovigilance system and applicable SOPsMain 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
Diegem, Brabant Flamand
Wed, 16 Oct 2024 03:08:10 GMT
To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesineu.com) you saw this job posting.
Location: Serravalle Scrivia - Italy Salary: Competitive Type: Permanent Main Industry: Search Management & Executive…
Location: Feuchy - France Salary: Competitive Type: Permanent Main Industry: Search Engineering Jobs Advertiser: Arkema…
Location: Norwich (NR6) - Norfolk, East Anglia, United Kingdom Salary: Up to £13.00 per hour…
Location: Hengelo (7559 SP) - Nederland, Netherlands Salary: Competitive Type: Permanent Main Industry: Search Engineering…
Location: Lyngby - Copenhagen, Zealand, Denmark Salary: Competitive Type: Permanent Main Industry: Search Electronics Jobs…
Job title: Dispatcher & Customer Service - Anderlecht - Service sector Company: Page Personnel Job…