Pharmacovigilance Compliance Lead — Frontline Operations

RXinsider LTD.

Orlando, Northern (FL, KY)

Hybrid

USD 111,000 - 139,000

Full time

14 days+

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Job summary

RXinsider LTD. in the United States is seeking an experienced Pharmacovigilance professional to support the PV Manager in frontline operations, ensuring compliant adverse event reporting and health authority readiness.

The role partners with QA, Patient Solutions, Regulatory Affairs, and Clinical teams to maintain robust drug safety processes. The ideal candidate will bring 7+ years in pharmacovigilance with a strong background in regulatory compliance, audits, and cross-functional

Qualifications

7+ years of pharmacovigilance/drug safety experience; 3+ years in a compliance/oversight/quality role
Strong knowledge of global PV regulations including ICH and GVP Modules
Experience with health authority inspections and audit readiness
Biopharmaceutical/biotech experience preferred
PV/compliance-related certification preferred
Familiarity with PV databases and safety signal detection tools
Experience cross-functional collaboration and stakeholder management
Proficiency in quality reporting tools and performance metrics
Experience drafting procedures and training programs
Strong organizational and leadership skills in front-end operations
Excellent collaboration and communication skills
Ability to identify, assess, and report adverse events

Responsibilities

Drive PV compliance activities to meet global regulatory requirements with QA and operations
Develop and manage PV compliance frameworks, SOPs, processes, and systems
Collaborate with cross-functional teams to support PV compliance
Ensure PV systems are audit-ready and support inspections
Assess PV risk, identify gaps, and implement improvements with QA
Monitor regulatory changes and communicate impact to stakeholders
Oversee PV quality performance of internal and external resources
Support PV audits of business partners and service providers
Contribute to PV training materials for frontline teams
Prepare and submit regulatory filings related to PV
Assist investigations of compliance breaches and CAPAs
Engage in continuous PV process improvement
Develop associate training materials on program enhancements
Participate in source data verification for PV QC
Identify and report adverse events
Document and report safety information
Lead interviewing, hiring, training, coaching, and performance reviews