Senior Specialist, Pharmacovigilance

ConnectiveRx

. Handle escalated Pharmacovigilance concerns from clients, junior PV staff, and Contact Center employees .

Posted 11/2/2026full-timeUnited StatesSenior💰 $61,000 - $92,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Pharmacovigilance practices, including compliance with FDA regulations and effective communication of medical information. Proficient in Quality Management systems and capable of conducting audits and training in a healthcare environment.

Highest-signal resume keywords

Pharmacovigilance ExperienceFDA Regulations KnowledgeQuality Management System ProficiencyAdverse Event ClassificationTraining and Coaching Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceQuality ControlQuality AssuranceAdverse Event IdentificationMedical TerminologyData ReconciliationReport SubmissionCAPA DocumentationRegulatory ComplianceAudit Execution

Soft Skills

Problem-SolvingCommunication SkillsCoaching AbilityAttention to DetailVerbal Comprehension

Tools & Technologies

Microsoft Office SuiteTrackwise DigitalSpartaTalent LMSCRM Systems

Industry Keywords

PharmacovigilancePostmarketing Safety Reporting21 CFR 314.8021 CFR 822SOC1SOC2PCIHIPAA

About the role

Key responsibilities & impact

Handle escalated Pharmacovigilance concerns from clients, junior PV staff, and Contact Center employees
Provide advice and recommendations on best practices and coach leaders and contact center staff on Pharmacovigilance matters
Troubleshoot problems and document and perform Corrective and Preventive Actions (CAPA) for non-conformances
Review Pharmacovigilance reports for accuracy and completeness
Use reporting forms and portals appropriately and enter reports into Quality Management and manufacturer databases
Submit reports to drug 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 using Quality Management, phone, CRM, and other systems
Reconcile manufacturer records with ConnectiveRx records and resolve discrepancies
Evaluate and update Standard Operating Procedures and Work Instructions
Create Pharmacovigilance educational content and lead or assist with training
Review Pharmacovigilance content in new or revised client contract agreements with legal and contract teams
Monitor compliance through call monitoring, source-document review, direct observation, internal auditing, and quality assurance/quality control activities
Document compliance-monitoring results in the Quality Management System
Assist Enterprise Quality leadership with RFP and audit support and preparation for third-party audits
Perform Pharmacovigilance audits of subcontractors and suppliers

Requirements

What you’ll need

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 required
Experience preferably in a call center, claims processing, and/or HUB service operations center
Quality control / Quality Assurance experience is a plus
Solid understanding of FDA regulations related to Postmarketing Safety Reporting requirements under 21 CFR 314.80 and 21 CFR 822
Ability to identify and classify serious and non-serious adverse events, other safety information, and product quality complaints
Basic understanding of medical and clinical terminology
High level of reading and verbal comprehension
English required; Spanish or other languages considered a plus
Ability to clearly and concisely articulate medical and clinical information to manufacturer representatives
Problem-solving skills to resolve concerns and escalated issues
Proficiency with Microsoft Office suite, including Outlook, Word, Excel, and PowerPoint
Ability to learn and successfully utilize Quality System tools such as Trackwise Digital/Sparta and Talent LMS
Up to 15% travel may be required
Ability to comply with SOC1, SOC2, PCI, HIPAA, company policies, client policies, and applicable laws

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Life insurance
Disability insurance
401(k) plan
Paid time off (PTO) for vacations and personal leave
Sick Time Off (STO) in accordance with company policy
Eight standard company holidays annually
Three floating holidays annually