Safety Data Management Specialist (m/f)

Zurich  ‐ Onsite
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Description


We are looking for a
Safety Data Management Specialist (m/f)

Reference: -en
Start: asap
Duration: 6 MM
Place: in Zürich
Branch: Grosshandel mit pharmazeutischen Erzeugnissen

Your tasks:
  • Carry out case processing activities of adverse events/adverse drug reactions
  • Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
  • Review case criteria to determine the appropriate workflow for case processing
  • Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
  • Write and edit the case narrative
  • Determine and perform appropriate case follow-up, including generation of follow-up requests
  • Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios
  • Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation
  • Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
  • Determine reportability of scheduled reports , ensuring adherence to regulatory requirements
  • Consistently apply regulatory requirements and Pfizer policies
  • Participate, as appropriate, in local, internal and external safety activities


Your qualifications
  • Professional in health care (e.g. nurse) or equivalent experience preferred
  • Experience in pharmacovigilance and/or data management, clinical care or clinical/scientific research preferred but not required
  • Experience in use and management of relational databases preferred
  • Good knowledge in medical terminology
  • Ability to solve routine problems under supervision and to surface issues constructively
  • Ability to make basic decisions with an understanding of the consequences
  • Fluency in spoken and written English and German
  • Good understanding of written French
  • Good understanding of written Italian is an advantage



Skills:
- Drug safety manager
Start date
ASAP
Duration
6 MM
From
Hays AG
Published at
24.03.2017
Contact person:
Kerstin Werner
Project ID:
1312353
Contract type
Freelance
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