Drug Safety Manager Jobs (NOW HIRING)

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.

Educational Qualification/ Experience Required:
    regulations and regulatory guidelines, contractual agreements, product-specific information and database/systems functionality.
    Communication of questions clearly and concisely to the appropriate audience, providing possible solutions where appropriate
    High School graduate in the US
    Education to GCSE level in the UK
    Previous office experience desired
    Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Drug safety experience is desired.
    Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred.
    Basic written and verbal communication skills
    Ability to sort, index and transmit fax/electronic documents
    Good computer skills (Word, Email) and familiarity with safety systems
    Data entry experience
    Ability to work independently and accountability for delivery of results
    Decision making skills
    Ability to follow procedural guidelines, working practices, etc.
    Quality orientation with attention to detail and accuracy
    Demonstrated Flexibility/Adaptability with positive attitude
    Good team player willing to collaborate
    Understanding of medical terminology and ability to summarize medical information