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