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Herakles Pharma

Drug Safety Associate / Drug Safety Officer

Functiegroep: Drug Safety (PV)
Werkweek:40 uur
Procedure: Detachering
Vacature ID:#508

Drug Safety Associate / Drug Safety Officer

De organisatie

Our client Novartis is a world leader in pharmaceutical health care. The company has more than 50.000 employees in more than 100 countries . They focus their efforts and expertise in seven disease areas and their goal is large in scope but simply stated: they work to discover new ways to improve and extend people’s lives. Novartis works closely with over 800 patient advocacy organizations, multiple leading research institutions, and other key stakeholders around the world to enhance their science-based innovation and deliver these life-saving treatments to people who need them.

De functie

For our client Novartis Herakles is looking for a Drug Safety Associate / Drug Safety Officer. In this role you will:

Support management of Patient Safety operational processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis group marketed and investigational products (drugs and devices).

Major Accountabilities:

  • Prepares the respective submission documents to Health Authorities;
  • Supervision of proper flow of confirmations of receipt of documentation sent to the Health Authorities;
  • Preparation and everyday distribution of respective DS&E documents externally;
  • Participation in the verification process of data correctness in the global safety database;
  • Verification of correctness and compliance of documentation;
  • Internal documents translation;
  • Verification if a document grant the safety requirements of the internal materials as described in respective Novartis procedures;
  • Preparation of training materials (incl. confirmations) and logistic organization of these trainings.

Het profiel

Requirements for the function as Drug Safety Associate / Drug Safety Officer

  • A degree in medicine or pharmacy, or Biomedical Science;
  • Fluent in English AND Dutch (oral and written);
  • Experience on similar position in drug safety or drug registration or clinical research department would be an additional asset;
  • Proven ability to work in cross-functional teams;
  • Computer technical skills (e.g. Excel, Word, Power Point) and ability to learn new systems quickly.

Het aanbod

Initially a one year contract is offered.

Inlichtingen bij

Interested in this position as Drug Safety Associate / Drug Safety Officer? Contact Rob Helmich or +31 6 538 538 92.

Meer informatie Rob Helmich +31 6 53853892 Stel een vraag

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