Drug Safety Assistant

• Execution of local activities relevant to the management of safety data.

• Monitor and manage dedicated DSU mailboxes

• Maintain local documentation as required by legislation (including archiving/tracking/retrieval) – lifting of boxes 

• Support the submission and distribution of reports and relevant tracking 

• Support distribution and tracking of distribution of Follow-Up letters

• Support inspection preparedness activities policies and practices as per Company SOPs

• Consistently apply Archiving policies as per Company SOP. 

• Basic understanding of Pharmacovigilance

• Demonstrated computer literacy

• At least 2 years’ experience in the use and management of relational databases

• Ability 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.

• Candidate must have a 4 year degree.

• Manager is seeking candidates with 1-3 Years Drug Safety Experience

• 1-3 years of regulatory experience required

Warm Regards

Ricky Bansal

732-429-1925