Mandy Pace Email & Phone Number

United States

Morristown, NJ

Provided detailed failure analysis of non-compliant single case reports (late cases) in co-operation with GPV functions. Liaised with GPV external partners to communicate non-compliance. Performed corrective actions and/or preventive actions (CAPA) management for identified quality issues related to ICSR GPV tasks and procedures. Provided management.

Morristown, NJ

Responsible for processing of Individual Case Safety Reports (ICSRs) received from internal and external customers for reporting to local and global regulatory authorities within reporting timelines. Prioritized and performed assessment, preparation, interpretation, and documentation of these adverse events into the global database for global distribution.

Nutley, NJ

Managed product inquiries received by phone, mail, and email from internal and external customers in an efficient and timely manner. As the first point of contact, ensured adverse events/product technical complaints were handled as per SOP guidelines to ensure timely reporting to health authorities. Conducted literature searches utilizing PubMED upon.