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Safety Data Management Specialist
Eingestellt von Synectics
Projektbeschreibung
PRIMARY RESPONSIBILITIES:
- Carry out case processing activities
- 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 company policies
- Participate, as appropriate, in local, internal and external safety activities
SKILLS:
TECHNICAL SKILL REQUIREMENTS:
- At lease 3 years experience required
- Experience in pharmacovigilance and/or data management preferred but not required
- Experience and skill with medical writing an advantage
- Demonstrated computer literacy
- Experience in use and management of relational databases preferred
- 1-3 years MS Excel & MS Word desired
- Clinical experience outside of an educational institution preferred
- Safety experience desired
- Argus experience is very strongly preferred
QUALIFICATIONS (IE, PREFERRED EDUCATION, EXPERIENCE, ATTRIBUTES):
- Health Care Professional or equivalent experience preferred
- Ability, with supervision, to solve routine problems and to surface issues constructively
- Ability to make basic decisions with an understanding of the consequences
- Ability to achieve personal objectives while meeting departmental standards of performance
- Ability to work under supervision in a Matrix organization
- Fluency in spoken and written English
Projektdetails
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Einsatzort:
Bridgewater, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges