Current Openings
Those interested should submit a cover letter and resume indicating specific position listed in each functional area. Correspondence may be sent via the address indicated below:
ViroPharma Incorporated
Human Resources Department
397 Eagleview Boulevard
Exton, PA 19341
Fax: (610) 458-7380
E-mail: careers@viropharma.com
Currently, opportunities are available in the following areas:
(Please select a job title to review the individual job descriptions)
Clinical Research Associate (CRA) - Full Time - Europe
Contracts Administrator - Full Time
Drug Safety Specialist - Full Time
Head of Pre-Clinical - Full Time
Quality Assurance - Full Time - Europe
Senior Analytical Chemist - Full Time
Senior Drug Safety Specialist - Full Time
Clinical Research Associate
Position Description: ViroPharma is seeking an experienced Clinical Research Associate to work in-house providing assistance and support to office and field-based staff in connection with the set-up and running of clinical research studies.
Requirements:
- Bachelors Degree in nursing, life sciences or a similar combination of education and experience
- Thorough knowledge of clinical research principles and FDA regulatory requirements.
- Good verbal and strong written communication skills.
- Highly organized.
- Detail oriented.
- Ability to multi-task and work in a flexible and dynamic organization.
- Willingness to travel occasionally
- Must be proficient in Microsoft Word and Excel.
Responsibilities:
- Review of regulatory packages to determine any deficiencies
- Making appropriate and timely site contact
- Providing field-based team with support
- Maintaining files/archives
- Working with administrative support to prepare documents/binders for CRA team/sites
- Producing/maintaining reports on study progress
- Preparation for Investigator Meetings
- Overseeing site payment process
- Overseeing contractual process
- Assisting with in-house audits (as required)
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Drug Safety Specialist
Position Description:Responsible for collecting and processing adverse event reports for clinical trials, compassionate use trials, and marketed products. Assists in the development of safety surveillance processes and writing corresponding SOPs. Assists with other safety surveillance related activities as needed.
Requirements:
- Education: Bachelors of Science degree in Nursing or Bachelor’s degree in a scientific discipline with clinical experience
- Work Experience: minimum 5 years clinical experience; minimum 3 years pharmaceutical experience with 2 years specific safety surveillance experience preferred.
- Excellent interpersonal, communication, and writing skills.
- Exceptional organizational skills, ability to multi-task and be detail oriented.
- Strong commitment to quality.
- Proficient with:
- Microsoft Windows XP.
- Microsoft Office 2003 - Word, Excel, POWERPoint.
- ARISg or equivalent electronic safety database system.
Responsibilities:
- Receive clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed; ensure that all SAEs are complete prior to database closure.
- Process and distribute clinical study SAE reports as per regulatory requirements and company SOPs; includes use of ARISg and writing intricate narratives for complex studies with critically ill patients.
- Track outstanding SAE issues within a clinical trial management system (i.e., LYNX).
- Complete AE/SAE reconciliation prior to clinical trial database lock.
- Ensure that all SAEs are complete and closed prior to database lock.
- Receive, process, and distribute spontaneous adverse event reports for marketed products, both serious and non-serious, as per regulatory requirements and company SOPs.
- Process all types of adverse event reports utilizing the ARISg safety database.
- Interface with Medical Directors, Medical Affairs, Regulatory, Medical Writing, Biostatistics, Clinical Operations, and Data Management departments.
- Assist with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested.
- Assist with providing safety support and training for clinical, monitoring, and site personnel as needed.
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Senior Drug Safety Specialist
Position Description: Responsible for collecting and processing adverse event reports for clinical trials, compassionate use trials, and marketed products. Assists in the development of safety surveillance processes and writing corresponding SOPs. Assists with other safety surveillance related activities as needed.
Requirements:
- Education: Bachelors of Science degree in Nursing or Bachelor’s degree in a scientific discipline with clinical experience
- Work Experience: minimum 5 years clinical experience; minimum 3 years pharmaceutical experience with 2 years specific safety surveillance experience.
- Excellent interpersonal, communication, and writing skills.
- Additional requirements:
- Microsoft Windows XP.
- Microsoft Office 2003 - Word, Excel, POWERPoint.
- Industry recognized safety database (e.g., ARISg or equivalent).
Responsibilities:
- Receive clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed; ensure that all SAEs are complete prior to database closure.
- Process and distribute clinical study SAE reports as per the company SOPs.
- Document safety review plans for assigned clinical trials.
- Complete AE/SAE reconciliation prior to clinical trial database closure.
- Receive, process, and distribute spontaneous adverse event reports for marketed products, both serious and non-serious, as per the company SOPs.
- Process all types of adverse event reports utilizing the ARISg safety database.
- Interface with Medical Directors, Medical Affairs, Regulatory, Medical Writing, Biostatistics, Clinical Operations, and Data Management departments.
- Assist with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested.
- Assist with providing safety support and training for clinical, monitoring, and clinical site personnel as needed.
- Direct activities of Clinical Research Associate and other staff as needed, in the collection and review of adverse event reports.
- Assist with implementing safety surveillance processes and establishing appropriate SOPs.
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