Responsibilities:

• Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary.
• May work with data management in the ongoing development and maintenance of databases.
• Responsible for supporting the GCSP with safety data analyses data retrieval from the GCSP safety database. Provide PL/SQL to analyses the safety database and/ or retrieve data as needed. In addition, other software tools will be used as appropriate. Contribute to the establishment of standard programs, standard procedures and work practices to ensure quality control and audit trails for analyses appropriate for regulatory submissions and publication.
• This role has global responsibilities with potential for matrix management , participation in global teams, and requires skills in leadership without formal authority.

• Requires medical background with 3+ years' pharmaceutical experience.
• Previous experience and/or knowledge of Pharmacovigilance.
• Good understanding of medical terminology.