Drug Safety Associate
2 Independece Way Princeton, NJ 08540
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.