Two Associates to Pharmacovigilance & Safety in AJ Vaccines

AJ Vaccines

Fuldtidsjob
Storkøbenhavn

We are saving lives worldwide. Would you like to join?

Do you always have attention on the detail, with an interest in health care and flair for administration? Then you may be our next colleague! We’re looking for two new team members who are motivated to grow and strengthen the pharmacovigilance function in Regulatory Affairs.

The responsibilities and ambitions of the team

The Pharmacovigilance & Safety unit is responsible for the evaluation and surveillance of our products. The unit plays a key role linking Regulatory Affairs and Medical Affairs in AJ Vaccines, by compiling and communicating medical safety information to be used, for example, in the product information.

In our unit we ensure that a robust system is in place for collection and communication of drug safety related information to local authorities and partners. The unit is in the process of expanding to meet requirements. You will have an active role in the daily operations in a growing unit where sparring and knowledge sharing are a natural part of everyday life. You will become an integrated part of the entire Regulatory Affairs meeting motivated and dedicated colleagues and your daily work will be in an social, humorous but still professional work environment.

Your work tasks

Your role will primarily be to support and maintain an efficient Pharmacovigilance system meeting the international regulations and secure compliance with AJ Vaccines procedures/SOPs.

The overall responsibilities and ambitions of the open positions are to:

  • Strengthen daily operations within case handling
  • Maintain current systems
  • Consolidate routine of surveillance
  • Implement robust and intelligent structures

This means that you will be responsible for the following activities:

  • Handle adverse event reports incl. receiving, evaluating, archiving, and reporting the cases
  • Follow-up on reports with health authorities, health care professionals, and customers
  • Assure compliance with agreed timelines
  • Assure compliance with regulations and company procedures
  • Routine screening of scientific literature
  • Develop and maintain internal pharmacovigilance procedures
  • Assure compliance on reconciliations
  • Ad-hoc support to Regulatory Affairs

Who are you?

The educational background required for this role is preferably medical secretary for health care professionals, nurse or another health care education combined with administrative interest and flair, or you have just finalized your master in science and have an interest in pharmacovigilance and safety.

You are proud of your administrative and service-oriented flair. Deadlines are to be met on weekly basis and it is therefore important to be structured and organized in your approach to tasks and insisting overview. Attention to details is needed in the daily work e.g. when handling cases and when screening the scientific literature. You have a good sense of flexibility since a part of your job responsibilities is to support the entire department on ad hoc administrative tasks..

In addition, we expect you to:

  • Be fluent in written and spoken English
  • Master Microsoft applications like Word and Excel, and be experienced with the use of databases, e.g. Access
  • Have knowledge of pharmacovigilance and safety. This is an advantage, but not a must.

We offer

This position in Regulatory Affairs offers a great number of variable tasks within Pharmacovigilance and Safety and you will be a part of a pharmacovigilance department that is developing each day.

Would you like to know more?

If you have any questions or need further information, please contact Marie Jordan Loft, Global Pharmacovigilance & Safety on tel. +45 7229 7530 or via LOF@ajvaccines.com. If you recognize yourself in the role of Pharmacovigilance & Safety at AJ Vaccines, apply online before 20. Apr. 2020. We look forward to read your motivated application and targeted CV and hope that we can welcome you to the first day as our new colleague on 01 June 2020. We expect to conduct the first interviews during the month of April 2020.


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Ansøgningsfrist d. 01.06.2020
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Fuldtidsjob
Storkøbenhavn
Administration
Medicinal & Sundhed
Administration
IT - Software
Medicinal & Sundhed



AJ Vaccines - hurtigt overblik


AJ Vaccines
AJ Vaccines
AJ Vaccines produces and sells vaccines from the production site in central Copenhagen. The production is taken over from SSI, and was until January 2017 owned by the Danish Government.

Placering
Artillerivej 5
2300 København S
Logo: AJ Vaccines
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