Drug Safety Coordinator

Drug Safety Coordinator

At Mindlance, we strive to deliver value through the combination of right people, processes, technologies and program management solutions. Our methods include applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective. All in all, our expertise lies in providing trained and committed minds to help meet your business objectives, irrespective of the stage your business is in.

Job Description

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.

Qualifications

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