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Drug Safety Specialist (Max Duration)

Req #: 1700887
Location: Boudry, CH
Job Category: Medical
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene R&D Sarl
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Fixed Term
Job Level:
Travel:
Other Locations:Switzerland- Boudry

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

POSITION OVERVIEW

In the DSCI organization and with respect of Celgene΄s Global & DSCI Operating Procedures (SOPs) and Working Practices (WPs), the Drug Safety Specialist is in charge of the handling of Adverse Reaction (AR) and Serious Adverse Reaction (SAR) reports, of drafting various safety reports or documents to comply with Federal, European and International Regulatory requirements and/or internal needs and of ensuring the relevance and the quality of the information on the safety data used for decisions on risk/minimization and assessment.

KEY ACTIVITIES

  • Reception, triage, data entry (DE) and writing of case narrative of any (S)AR report under a company investigational medicinal product or marketed product received by DSCI Identification of (S)AR reports received by DSCI requiring follow-up investigations
  • Assessment of all (S)AR reports received by DSCI Quality Control of the DE for all (S)AR reports received by DSCI after their entry into the World Wide Drug Safety Surveillance (WWDSS)
  • Database Control of auto-scheduled labeledness of each individual AR in reports received by DSCI  Writing of PSUR and/or of safety reports or documents as well as review of the possible supporting line-listings
  • Review of the SAR reports received by the company worldwide for expedited reporting  Reporting of any potential safety issue in a timely, open and appropriate manner to line management
  • Monitoring of bibliography about product portfolio and safety subject matters and identification of its impact on the company products
  • Reconciliation between the WWDSS Database and CRO Clinical Databases as required.
  • Training on SAR collection and reporting to internal and external partners of DSCI as appropriate.
  • Identification of safety issues that should be brought to the attention to the group and Celgene International Regulatory Affairs (RA) in the perspective of updating the product label and presentation of the rational for any proposed updates of the Company Core Data Sheet safety sections of the company products
  • Contribution for drafting any type II variation dossier as appropriate
  • Contribution to safety evaluations and adequate alignment with safety requirements in the review of clinical trial protocols and investigator brochures. Contribution to Risk Management planning activities

SKILLS/KNOWLEDGE MINIMUM REQUIRED:

  • Minimum education level of a Degree Life Sciences with good medical knowledge or fully qualified Nurse or Pharmacist 
  • Previous experience (2-5 years) in a Drug Safety Department or Clinical Operations within a large pharmaceutical company appreciated
  • Good communication skills, including good English written and spoken.
  • Synthetic and analytic skills as well as accuracy in daily work required
  • Sound knowledge of databases such as those used for Drug Safety Surveillance and other software applications helpful.
  • Working knowledge of European Regulations governing SAR report collection, evaluation, processing, and submission for both investigational medicinal products and marketed product appreciate.
  • Basic computer skills required.

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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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