Pharmacovigilance Coordinator, Case Processing

This a Full Remote job, the offer is available from: United States, Serbia For the past 25 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.

• 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.

#LI-KP1 #LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*

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