Job description

The Case Management Specialist, has the primary responsibility for the preparation and timely submission of all safety reports, including intake, reconciliation, case processing & submissions. The Case Management Specialist will be responsible for collection, preparation and reporting of serious adverse events (SAEs)/Adverse Events for Clinical Trial and Post Marketing cases to ensure compliance with global regulatory requirements.

Principal Responsibilities

• Perform the initial triage of AEs/SAEs including complete data entry, coding of the events using MedDRA dictionary and the writing of concise narratives independently
• Manage the completion, routing, and approval of ICSRs in the Global Safety Database within the expected parameters of quality and timeliness
• Directly, or through internal functions and external personnel, conduct follow-up with clinical sites to obtain all pertinent adverse event information, and use appropriate questionnaires when required
• Assist with the maintenance, testing, and implementation of modifications to the Global Safety Database as required
• Review expedited reports for submission to regulatory authorities, business partners, CRO’s or study investigators
• AE/SAE reconciliation with Clinical, CRO’s, Business Partners, Med Info, Patient Support Program, Market Research Program etc.
• Assists in the preparation of internal and external reports in collaboration with a Senior Case Management Specialist or Case Management Manager
• Support interactions with business partners (license partners) and vendors for all case intake and processing activities
• Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts
• Interface with local office staff, vendors, and business partners for case processing as necessary
• Support other case processing functions as required
• Participate in the creation, review and revision of SOPs and procedures
• Support Audit & external inspection.
• Perform other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Qualifications

• Understanding of global regulatory requirements for pharmacovigilance
• Proficiency in safety system. ARGUS preferred.
• Case processing experience with demonstrated high case level productivity and quality
• Attention to detail
• Familiarity with clinical development process
• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

Education

• BS Pharmacy, PharmD, BS RN degree or life sciences degree

Job Type: Contract

Pay: $30.00 - $35.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift

Experience:

• ARGUS (Preferred)
• Adverse Event Case processing (Required)

Work Location: Remote

gatheringourvoice.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, gatheringourvoice.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, gatheringourvoice.org is the ideal place to find your next job.