Drug Safety Officer 80%

Location
Basel Area.
Salary
Competitive
Posted
09 Nov 2018
Closes
06 Mar 2019
Ref
896067-P
Contract Type
Contract

 

Main Responsibilities:

  • Case processing of safety data received from spontaneous reports, post-marketing study, clinical trial and literature;
  • Perform medical review and assessment for the cases;
  • Ensure consistency in case classification, seriousness, causality, labelling (Company Core Data Sheet (CCDS) and Summary Product Characteristic (SmPC), coding (MedDRA and WHO-DRUG) and narratives for all cases received from different worldwide sources;
  • Evaluate, identify and prioritize cases which are reportable according to our procedures to ensure timely and good quality management of individual case safety reports (ICSRs) and other safety information from various sources;
  • Generate queries;
  • Tracking cases and late case appropriately, tracking reconciliations of events internally and with partners;
  • Filing safety data;Assist to provide aggregate reporting of safety data;
  • Overview of Safety Data Exchange Agreements (SDEAS), and safety-relevant SOPs;
  • Interaction with other departments, CRO and partners;
  • Using Learning Management Systems (LMS) and training systems;
  • Knowledge of ICH guidelines and regulatory requirements.

Qualifications and experience

  • University degree Life science or para-medical (Bachelor minimum);
  • 3 - 5 years’ experience in PV/drug safety, ideally at headquarters level;
  • Experience interacting cross-functionally (i.e. Clinical Development, Regulatory Affairs);
  • Working knowledge of EU pharmacovigilance and marketed compounds. Knowledge of non-EU requirements would be an asset;
  • Excellent command of English (verbal and written), other languages German, French or Italian;
  • Ability to prioritize and plan effectively, and to manage multiple projects in a changing environment;
  • Communicative, open, accurate and reliable;
  • Strong organisation skills;
  • Team player and able to work effectively in a multidisciplinary environment;
  • High commitment to quality;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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