Sr. Specialist, Pharmacovigilance

ConnectiveRx • Hanover Township, NJ

3d • $61,000 - $92,100

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 the pharmaceutical programs and manufacturers it supports. The role helps maintain a state of control and audit-readiness regarding contractual obligations and applicable laws and regulations for pharmacovigilance activities.

The specialist reviews and monitors pharmacovigilance reports and related communications, supports reconciliation and audit activities, maintains procedures and training, and advises colleagues and clients on pharmacovigilance practices. The role also supports contract review, quality management, audit preparation, and subcontractor and supplier audits.

Requirements

• Bachelor’s or master’s degree in a science or healthcare field, or seven years of equivalent experience.
• Three to five 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 regulations for postmarketing safety reporting under 21 CFR 314.80 and 21 CFR 822, and how those requirements affect ConnectiveRx’s business and obligations to 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.
• High reading and verbal comprehension in English 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 comply with company policies, procedures, and training related to information security and compliance, including SOC1, SOC2, PCI, and HIPAA, as well as company and client business rules, ethics, and applicable laws.

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.

Responsibilities

• Handle escalated pharmacovigilance concerns from clients, junior-level PV staff, and contact-center employees; provide advice on best practices, coach leaders and staff, troubleshoot issues, and document and perform Corrective and Preventive Actions (CAPA) when non-conformances are identified.
• Review pharmacovigilance reports for accuracy and completeness; ensure appropriate use of reporting forms and portals; enter reports into ConnectiveRx’s Quality Management database and, when required, manufacturers’ databases; and submit reports to manufacturers on time.
• 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, supplying requested information, reconciling manufacturer and ConnectiveRx 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 legal and contract teams to review new or revised draft client agreements and ensure pharmacovigilance terms align with ConnectiveRx’s capabilities and service offerings.
• Monitor compliance with the ConnectiveRx Pharmacovigilance program through call monitoring, source-document review, direct observation, internal audits, and quality assurance or quality control activities; document results in the Quality Management System.
• Assist Enterprise Quality leadership with RFP and audit support and preparation for third-party audits.
• Perform audits of ConnectiveRx subcontractors and suppliers regarding pharmacovigilance activities.
• Perform other duties as assigned.

Benefits

• Medical, dental, vision, life, and disability insurance.
• 401(k) plan.
• Paid time off (PTO) for vacations and personal leave for non-exempt employees.
• Sick Time Off (STO) 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