Sr. Specialist, Pharmacovigilance

ConnectiveRx • Pittsburgh, PA

2d

About The Position

Under direct supervision of the department manager or supervisor, the Sr. Specialist, Pharmacovigilance helps meet ConnectiveRx’s drug safety monitoring and reporting obligations for pharmaceutical programs and drug manufacturers. The role supports a constant state of control and audit-readiness in relation to contractual obligations and applicable pharmacovigilance laws and regulations.

The specialist provides guidance and coaching on pharmacovigilance matters, reviews and submits safety reports, monitors compliance, and supports audits and reconciliation activities. The role also helps maintain procedures and training, reviews pharmacovigilance terms in client contracts, and coordinates with internal teams, manufacturers, subcontractors, and suppliers.

The position is primarily office-based and sedentary, with up to 15% travel. The employee uses standard office and computer equipment and communicates frequently with employees and external contacts by telephone and in writing.

Requirements

• Bachelor’s or master’s degree in a science or healthcare field, or 7 years of equivalent experience.
• 3–5 years of experience in a medical, pharmacy, or healthcare environment; call center, claims processing, or HUB service operations center experience is preferred within this requirement.
• Solid understanding of FDA postmarketing safety reporting requirements under 21 CFR 314.80 and 21 CFR 822, and how these requirements affect ConnectiveRx’s business and obligations to drug manufacturers.
• Ability to identify and classify reportable drug safety events, including serious and non-serious adverse events, other safety information, and product quality complaints.
• Basic understanding of medical and clinical terminology.
• Strong English reading and verbal comprehension to interpret audio and text source data.
• Ability to clearly and concisely communicate medical and clinical information to manufacturer representatives.
• Problem-solving skills to resolve concerns and escalated issues.
• Proficiency with Microsoft Office tools, including Outlook, Word, Excel, and PowerPoint, and ability to learn and use Quality System tools such as Trackwise Digital/Sparta and Talent LMS.
• Ability to perform primarily sedentary work, occasionally lift up to 20 pounds, and perform tasks requiring visual acuity, manual dexterity, grasping, and repetitive motions.
• Ability to operate standard office and computer equipment and communicate with employees and external contacts by telephone and in writing.
• Adhere to company policies, procedures, training, information security and compliance programs, and applicable business ethics and laws, including SOC1, SOC2, PCI, and HIPAA requirements.

Nice To Haves

• Quality control or quality assurance experience.
• Spanish or other language skills.
• Experience in a call center, claims processing, or HUB service operations center.
• Master’s degree in a science or healthcare field.

Responsibilities

• Handle escalated pharmacovigilance concerns from clients, junior PV staff, and Contact Center employees; advise on best practices, coach staff and leaders, troubleshoot problems, and document and perform Corrective and Preventive Actions when non-conformances are identified.
• Review pharmacovigilance reports prepared by ConnectiveRx associates for accurate and complete descriptions, appropriate use of reporting forms and portals, required database entry, and timely submission to drug manufacturers.
• Audit calls, faxes, and other patient and healthcare-provider communications to ensure pharmacovigilance data is captured and reported.
• Perform periodic reconciliation activities under the Manager of Pharmacovigilance’s guidance, including extracting data from relevant systems, reporting totals, providing requested information, reconciling manufacturer records, and identifying missed, late, incomplete, or discrepant reports.
• Evaluate and update pharmacovigilance Standard Operating Procedures and Work Instructions to maintain compliance with contracts, company and client policies, and applicable regulations.
• Maintain training compliance, create pharmacovigilance educational content, and lead or assist with training for new employees.
• Work with the legal and contract team to review pharmacovigilance content in new or revised client contract drafts for alignment with ConnectiveRx capabilities and services.
• Monitor compliance with the ConnectiveRx Pharmacovigilance program through call monitoring, source-document review, direct observation, audits, and quality assurance or quality control activities as directed.
• Document compliance-monitoring results according to the ConnectiveRx Quality Management System.
• Assist Enterprise Quality leadership with RFP and audit support and preparation for third-party audits.
• Audit subcontractors and suppliers with respect to pharmacovigilance activities.
• Perform other duties as assigned.

Benefits

• Medical, dental, vision, life, and disability insurance.
• 401(k) plan.
• Paid time off for vacations and personal leave for eligible non-exempt employees.
• Sick Time Off for eligible non-exempt employees in accordance with company policy.
• Eight standard company holidays and three floating holidays annually.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior