Kelly Services Drug Safety Coordinator I in Horsham, Pennsylvania
Kelly Services is seeking a Drug Safety Specialist I - to join on of our leading pharmaceutical clients in Horsham, PA for a contract W2 position.
JOB TITLE:Drug Safety Coordinator I
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.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.
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
Participate in GMSO projects, preparation for audits and inspections.
Activities Include :
Assist in supporting inspections and audits e.g., interviews, as required.
Provide support for local or global project teams.
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.
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
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.
This position reports to Manager/Associate Director, Case Receipt, GMSODELEGATION/BACKUP INFORMATION:
With Kelly®, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 99 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group- rate insurance options available immediately upon hire*
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place.
Let Kelly fuel your career—connect with us today.
For immediate consideration if you meed the requirements, please email a recent CV to Meghan.Porter@kellyservices.com
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is committed to employing a diverse workforce.
Why Kelly ® ?
At Kelly Services ® , we work with the best. Our clients include 95 of the Fortune 100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to access the best talent to drive their business forward. If you only make one career connection today, connect with Kelly.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm