Guerbet

Medical & Compliance Officer

Guerbet Brussels, Brussels Region, Belgium
Guerbet

Medical & Compliance Officer

Guerbet Brussels, Brussels Region, Belgium
2 weeks ago
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Jasmine Ben-Moumen Click here to view Jasmine Ben-Moumen’s profile

Jasmine Ben-Moumen

Talent Acquisition and Employer Branding Partner EMEA | South of Europe | France chez Guerbet

Job Description

Principal Responsibilities

  • 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
  • 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
  • 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
  • Regulatory Affairs (territories Belgium & Luxembourg)
  • Support RA manager in his/her activities
  • Local RA contact for medical devices
  • 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

Profile Description

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 & UK

Works 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.

  • Seniority level

    Entry level

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • Industries

    Pharmaceutical Manufacturing

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