Job Title: Drug Safety Coordinator I
Duration: 6 Months+
Location : Horsham, PA
Summary:
Responsible for the receipt and data entry of adverse event reports following Company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide
safety regulations and corporate policies.
Description:
• Case Registry/Entry: The preparation of a case, from receipt to initial assignment in the database.
• Activities include:
• Retrieval of cases from incoming faxes, files and/or electronic case receipt system, as applicable
• Creation of transmittal form and/or electronic documentation of key information, as applicable
• Liaison with Case Processing staff, to clarify information
• Clarification of unclear or illegible information with LSO, Call Centre, etc
• Conducting duplicate searches to determine if case is initial or follow-up
• Creation of case file (paper or electronic)
• Registry of case to complete basic data entry registry fields
• Assignment of MFR/AER number
• Send case numbers to LSOs/Call Centre, etc., as applicable
Case Processing: The completion of case information in the database,
culminating in Quality Review to ensure accuracy and completeness.
Activities include:
• Completion of remaining case data entry, including narrative or autonarrative for non-serious cases, as required
• Completion of transmittal form, if applicable
• Request deletions/edits, as necessary
• Processes and Procedures: Understand and follow GMS systems and procedures.
• Activities include:
• Completion of all assigned training on company and GMS procedural documents relating to case receipt/processing
• Completion of training for relevant PV Agreements for assigned products
• Provide assistance in supporting revision/creation of case receipt procedural documents
GMS Interfaces
• Frequent operational and project related contact with staff in GMS Operations (all functional groups), Occasional contact with GMS & GMS Operations, Quality Systems, PV Sciences (esp.PVPs), Strategic Planning (Compliance Standards and Alliance, SBPO, TPT, Regions), and Legal.
• Customer Interfaces
• Frequent operational and project related contact with relevant staff in assigned customer sector (Pharma/Consumer), including e.g. LSOs, clinical and regulatory affairs personnel, and Call Center personnel.
• Internal and external IT/IM partners – occasional project related contact.
• RDQA Partners – internal audit and inspection related contact.
• 3rd party partners – as required in support of products assigned to team.