Senior Pharmacovigilance Coordinator, Case Processing

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. As the world’s largest RCO (Research Consulting Organization), 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.

Job Summary :

The Senior Pharmacovigilance (PV) Coordinator, Case Processing assists PV Coordinator staff with entry of cases in the safety database. The Senior PV Coordinator oversees assigned mailboxes for client communications and assists with triaging questions. The Senior PV Coordinator maintains distinctive quality and commitment as the operating philosophy in carrying out all processes and continually seeks out ways to enhance customer service experience both internally and externally. The Senior PV Coordinator will be professional, diligent and liaise with Senior members on the team on any issues. The expectation is to lead by example and ensure quality standards are upheld.

Essential Functions :

• 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.
• Help oversee team workload and client deliverables to make sure that daily / weekly goals are hit by the collective intake team as needed.
• Other duties as assigned.

Necessary Skills and Abilities :

Educational Requirements :

Post-secondary education.

Experience Requirements :

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.