pharmacovigilance officer

 

job details

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summary

• mechelen
• contract
• 40 hours per week

• group function
  medical
• reference
  CXRSP-109970

job details

We are looking for a Drug Safety Officer for one of our clients based in Mechelen.

Don't hesitate to contact me: siham.haddouchi@professionals.randstad.be

...

We are looking for a Drug Safety Officer for one of our clients based in Mechelen.

Don't hesitate to contact me: siham.haddouchi@professionals.randstad.be

• key responsibilities

  Job purpose:

  Responsible for the management of PER activities requiring specific scientific experience and skills in the health products sector in line with the requirements of European and Benelux regulations.

  Main tasks:

  Pharmacovigilance:

  • Improve knowledge of applicable legislation.

  • Stay up to date with scientific developments relevant for the portfolio of the clients.

  • Be able to manage the dossiers individually and be able to manage important dossiers, also in cooperation with other countries where the PER services are required.

  • Preparation of PER services delivered by the LCPPV while ensuring that the dossiers are processed in accordance with the regulations in force and in compliance with the commitments made to clients.

  • Be the lead for some client contacts, manage the client needs. Become LCPPV for 2-3 small companies.

  • Take part in the 24/7 permanence.

  • Be actively involved in internal meetings with the company. Pro-active behaviour.

  • Participate in audits or diagnosis of dossiers.

  • Participate in achieving activities.

  • Comply with quality procedures.

  Key decisions:

  • Decision on suitability of market access related approaches after validation by project management.

  • Decision regarding projects planning, budgeting and organization after validation by project management.

  • Advisor to clients on pharmacovigilance procedures and requirements after validation by project management.

• qualifications

  • Successful completion of Pharmacist’s diploma or a scientific Master’s degree, or in some cases a specialized bachelor’s degree.

  • 2 to 5 years of professional experience and project management experience.

  • Good Knowledge of Dutch and English.

  • Strong knowledge of European regulatory requirements for medicinal products.

  • Distinctly strong service orientation.

  • Content-related experience in several relevant areas of Pharmacovigilance.

  • Ability to manage one or several activities with limited guidance.

  • Independent approach to work, flexibility and dedication.

  • Diplomacy, ability to communicate and integrate in an international and multicultural environment.

  • Strong sense of responsibility, organizational skills and intrinsic motivation.

  • Ability to manage internal and external (client) relationships on an operational / day-to-day working level.

  • Good knowledge of the MS-Office package.

  • Good communication skills (written and verbally); capability to communicate issues and propose solutions.

• key benefits

  Consultancy

  We offer an attractive salary with extra-legal advantages:

  • Group insurance

  • Hospitalisation insurance

  • Meal vouchers of 7 euros gross per working day

  • Reimbursement km or company car

  • Monthly allowance (80 euros net per month)

  • A 13th month

  • Training

  • Etc.

  A rate as a freelancer is also possible.

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