Pharmacovigilance Senior Specialist: Drug Safety Expert

ConnectiveRx; Pittsburgh (Allegheny County); On-site; USD 61,000 - 92,000; Full time

Benefits offered by this job

Medical, dental, vision, life, and ADP

401(k) plan

Paid time off and holidays

Job summary

ConnectiveRx in Pittsburgh seeks a Sr. Specialist, Pharmacovigilance to ensure drug safety monitoring and regulatory reporting across client programs. You will review PV data, drive CAPA, and maintain audit readiness under supervision of the PV Manager.

You will contribute to SOP maintenance, training, and cross‑functional audits while ensuring accuracy of safety communications and timely reporting to manufacturers.

Qualifications

• Bachelor’s or master’s degree in science or healthcare field, or 7 years equivalent experience.
• 3-5 years of experience in a medical, pharmacy or healthcare environment (preferably call center or claims processing).
• Must have a solid understanding of FDA Postmarketing Safety Reporting requirements under 21 CFR 314.80 and 21 CFR 822.
• Strong English reading and verbal comprehension; Spanish or other languages a plus.

Responsibilities

• Handle escalated PV concerns and advise on best practices; coach staff on PV matters.
• Review PV reports for accuracy; ensure proper forms, portals, and reporting timelines.
• Perform periodic reconciliation activities across QMS, phone/CRM systems, and manufacturer records.
• Update SOPs and Work Instructions to ensure regulatory and contract compliance.
• Support training initiatives and assist with audits and training content creation.

Skills

Pharmacovigilance

Problem-solving

Communication

Microsoft Office

Education

Science/Healthcare degree

Tools

TrackWise Digital/Sparta

Talent LMS

Job description

ConnectiveRx in Pittsburgh seeks a Sr. Specialist, Pharmacovigilance to ensure drug safety monitoring and regulatory reporting across client programs. You will review PV data, drive CAPA, and maintain audit readiness under supervision of the PV Manager.

You will contribute to SOP maintenance, training, and cross‑functional audits while ensuring accuracy of safety communications and timely reporting to manufacturers.