Pharmacovigilance Coordinator, Case Processing
About the position
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Pharmacovigilance (PV) Coordinator, Case Processing, monitors and triages the communications received via the PV inbox. The Coordinator performs data entry of (Clinical & Post-Marketing) cases received via email or fax. The Coordinator generates and distributes deliverables from the safety database as assigned in accordance with the safety management plan and maintains distinctive quality and commitment as the operating philosophy in carrying out all processes. The Coordinator continually seeks out ways to enhance customer service experience both internally and externally.
Responsibilities
• Manage assigned mailboxes, including inbox triage of client communication, inbound reports, and internal case processing communications.
• Perform Duplicate searches and complete initial book-in as required.
• Screen and redact the source documents for PHI as per company procedures.
• Facilitate literature related activities as needed.
• Initial triage of regulatory authority database searches.
• Send draft reports to clients for review as needed.
• Enter basic data into safety database as required such as identifiable patient, report, suspect drug, and adverse event.
• As applicable perform full data entry into safety databased with proper experience and training.
• Other duties as assigned.
Apply tot his job
Apply To this Job
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Pharmacovigilance (PV) Coordinator, Case Processing, monitors and triages the communications received via the PV inbox. The Coordinator performs data entry of (Clinical & Post-Marketing) cases received via email or fax. The Coordinator generates and distributes deliverables from the safety database as assigned in accordance with the safety management plan and maintains distinctive quality and commitment as the operating philosophy in carrying out all processes. The Coordinator continually seeks out ways to enhance customer service experience both internally and externally.
Responsibilities
• Manage assigned mailboxes, including inbox triage of client communication, inbound reports, and internal case processing communications.
• Perform Duplicate searches and complete initial book-in as required.
• Screen and redact the source documents for PHI as per company procedures.
• Facilitate literature related activities as needed.
• Initial triage of regulatory authority database searches.
• Send draft reports to clients for review as needed.
• Enter basic data into safety database as required such as identifiable patient, report, suspect drug, and adverse event.
• As applicable perform full data entry into safety databased with proper experience and training.
• Other duties as assigned.
Apply tot his job
Apply To this Job