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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.
Case Registry/Entry: The preparation of a case, from receipt to initial assignment in the database.
• 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.
• Completion of remaining case data entry, including narrative or auto-narrative for non-serious cases, as required
• Completion of transmittal form, if applicable
• Request deletions/edits, as necessary
Processes and Procedures: Understand and follow GMSO systems and procedures.
• Completion of all assigned training on company and GMSO 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
Project Work, Audits, Inspections and other Ad-hoc Requirements: Participate in
GMSO projects, preparation for audits and inspections
• Assist in supporting inspections and audits (e.g., interviews, as required)
• Provide support for local or global project teams
Mentoring: Enhancement of the formal training program, through the provision of on-going, on-the-job guidance and support
• Assist with provision of on-the-job training and support to other Safety Coordinators
Personal Development: Continuous development of personal skills, whether task or competency-related
• Technical training & e-Learning
• Workplace shadowing
• Mentoring others
• Project involvement
• Soft skill development activities
• Results & Performance Driven (GLP)
• Sense of Urgency (GLP)
• Big Picture Orientation & Attention to Detail (GLP)
• Collaboration and Teaming (GLP)
• Integrity & Credo Based Actions (GLP)
• Expertise in operations activities including case receipt (or other functional expertise).
DECISION-MAKING AND PROBLEM-SOLVING:
• Application and knowledge within single case receipt context of: GMSO processes and guidelines, 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.
REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides.
This position reports to Manager/Associate Director, Case Receipt, GMSO
DELEGATION/BACKUP INFORMATION: List duties of this position that are delegated to another party with indication of responsible job title. Also describe, as appropriate, nominated person contact details, 24-hour availability & backup information.
RESPONSIBILITY FOR OTHERS (If applicable): Please select the classification of position(s) supervised below.
WORKING RELATIONSHIPS/INTERFACES: Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature.
Global Medical Safety Operations (GMSO) is a functional area within the Global Medical Organization (GMO)
Frequent operational and project related contact with staff in GMSO (all functional groups),
Occasional contact with GMSO, Compliance Strategy and Analytics (CSA), SBPO, TPT, Regions), and Legal.
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.
Bio Research Quality and Compliance (BRQC) Partners – internal audit and inspection related contact.
3rd party partners – as required in support of products assigned to team.
EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.
Required Education / Training and/or Experience
• 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
• Proactive approach/uses own initiative appropriately
• Flexibility and adaptability with a positive attitude
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