Drug Safety Associate

Princeton, NJ 08540

Posted: 09/16/2019 Industry: Biotech/R&D/Science Job Number: 49538

Job Summary

Safety Data Exchange Agreements
Compliance monitoring / audit support
SOPs and training coordination
Regulatory report submissions
Pharmacovigilance related systems 
 

Area Of Responsibility

Responsible for the following but not limited to:

Safety Data Exchange Agreements including drafting, maintenances of agreements, ADE exchange, ADE reconciliations, etc. 

Compliance monitoring of procedural and regulatory obligations, support inspections, draft deviations and track CAPAs, quality review of ADEs

Coordinate SOP and training activities, prepares training calendars, ensures timely trainings and SOP revisions

Ensure timely submission of ICSR and periodic report submissions for adverse drug events 

Support managing systems related to Pharmacovigilance

 

Education and Job Qualification

Bachelors degree preferred. Candidates who qualify based on relevant experience may be considered. 

Melissa Valazza

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