Temporary position as a Submission Officer for a period af 6 months in the pharmaceutical industry (Leiden, The Netherlands)
- diverse job within a pharmaceutical company
- interesting because of the specialist work in regulatory affairs
- temporary contract with the possibility to extend
Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has a tight line all around the world. For the regulatory department they look for support. Therefore they would like to meet a committed Submission Officer for an enthusiastic team.
As a Submission Officer you will be responsible for executing all in-house submission activities both for ICSRs and for periodic reports to EU competent authorities, ethics committees, investigators and DSOs, as applicable. Timely submission is critical to maintain compliance. Your mainly responsibilities are to perform ICSR and periodic submissions to competent authorities, ethics committees and investigators as per reporting rules in Argus. You ensure compliance with regulatory and contractual timelines and follow a proper tracking of all activities to allow accurate compliance measurements. You will perform ICSR distribution to license partners and failure to achieve results typically results in significant compliance risks. Distribution of literature articles are also your responsibility. As well as alerting the PV process configuration manager in case of identified errors in reporting algorithm. You assist in root cause analysis in case of compliance issues. You report to the manager of the department for the submission process.
- Bachelor degree in a relevant field
- experience in a similar position in Regulatory affairs or Pharmacovigilance
- experience in the pharmaceutical industry
- trained in relevant internal processes and procedures
- self-directed within the scope of their duties and responsibilities
- quality minded to review the deadlines and results
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-043-MB, to Sandra van Putten: email@example.com. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.
Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
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