Drug Safety Officer

  • Fulltime
  • Tijdelijk
  • Leiden, Nederland
  • Referentienummer: DT/20-064-DD

Derks & Derks Detachering

Temporary position for 7 months at a pharmaceutical company

Offer

  • a diverse job at a global pharmaceutical company
  • an interesting job because of the international contacts
  • a temporary contract for 7 months, with the possibility to extend

Organisation

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 tight lines all around the world. The organisation is looking for a Drug Safety Officer.

Position

As a Drug Safety Officer you will be managing its related duties and act as a contact person for any safety issues at the responsible country and/or Affiliate. You will lead and, if applicable, provide effective management of PSI. Ensure that safety information (Adverse Events) received from all sources by the Affiliate are collected, translated and forwarded to designated Regional PV HQ, in compliance with required timelines (reporting timelines), quality guidelines and standards. If applicable: Timely ICRS submissions to the Competent Authority. You will also ensure the Affiliate is GPvP inspection and audit ready and support a PV audit or inspection if needed. Another field  of responsibility is to provide input for the PSMF regarding the Affiliate communication to GPV Regional HQ. You will also be responsible and accountable for PV self-assessments, PV audits/inspections at the Affiliate and assist in developing CAPAs (with qualitative/quantative measures and timelines) in response to findings/observations. If the position is not various enough you also serve as a point of contact for the PV Regional HQ functions, PV Affiliate Support Function, the Affiliate MT and M&D functions. You report to the manager of the department and interact with your global and local team.

Profile

  • minimum B.Sc. degree in Life Sciences
  • in depth knowledge of regulatory requirements
  • technical expert or manager with an in-depth understanding of all aspects of pharmacovigilance and related disciplines
  • experience in leading a team, project or process function
  • a strong cultural sensitivity, influencing skills without direct hierarchy
  • good oral and written communication and presentation skills in English
  • willingness to travel up to 50%

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-064-DD, to Sandra van Putten: info@derksenderks.nl. 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 Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Is this not the job you are looking for? Please visit www.derksenderks.nl/nl/nieuwe-baan/vacatures for other challenging positions in pharma, food and medical.

Tagged as: Life Sciences

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