Manager, Pharmacovigilance

AssistRx; Orlando (FL); On-site; USD 111,000 - 139,000; Full time

Job summary

AssistRx, Inc. is seeking a seasoned PV Specialist to support the PV manager in frontline operations, including adverse events, product quality complaints, and medical inquiries, ensuring timely reporting and regulatory adherence.

Collaborate with QA, Patient Solutions, Operations, and Compliance to maintain audit-ready PV systems and drive continuous improvement. Requires a bachelor’s in life sciences and 7+ years in pharmacovigilance with 3+ years in a compliance/quality role.

Qualifications

• 7+ years of experience in pharmacovigilance/drug safety.
• 3+ years in a compliance, oversight, or quality-driven role.
• Strong knowledge of global PV regulations, including ICH guidelines and GVP Modules.
• Experience with health authority inspections (DEA, State Board of Pharmacy, URAC/ACHC, OIG, etc.) and audit readiness.
• Biopharmaceutical or biotech experience preferred.
• Certification in pharmacovigilance or compliance preferred.
• Familiarity with PV databases and safety signal detection tools preferred.

Responsibilities

• Drive PV compliance activities to meet global regulatory requirements and integration with QA and Patient Solutions.
• Develop, implement, and manage PV compliance frameworks, SOPs, processes, and systems for drug safety reporting.
• Collaborate with cross-functional teams to enable a patient-centered PV compliance approach.
• Ensure PV systems are audit-ready and support regulatory inspections.
• Assess PV risk and address compliance gaps with QA and Patient Solutions.
• Monitor regulatory changes and inform stakeholders.
• Oversee performance of internal and external resources and report to senior management.
• Support PV audits of partners and service providers and communicate findings.
• Contribute to PV training materials for frontline teams.
• Facilitate preparation and submission of regulatory PV filings and risk management plans.
• Assist with CAPAs and continuous improvement initiatives.
• Engage in program enhancements and associated training for AE, PQC, and MI handling.

Skills

Pharmacovigilance

Regulatory knowledge

Stakeholder management

Quality improvement

Education

Bachelor’s degree in Life Sciences

Tools

PV databases

Safety signal tools

Job description

Overview

This role is responsible for supporting the Pharmacovigilance (PV) Manager in frontline operational support for PV activities, including the identification, documentation, and reporting of adverse events (AE), product quality complaints (PQC), Medical Inquiry (MI) and in compliance with program requirements and timeliness standards. The role directly interfaces with Quality Assurance, Patient Solutions, Operations, Compliance, and clients.

Responsibilities

• Drive the execution of PV compliance activities to meet global regulatory requirements (DEA, State Board of Pharmacy, URAC and ACHC, OIG, etc.) and industry standards, with a focus on operational integration with Quality Assurance and Patient Solutions.
• Partner closely with Quality Assurance and Operations to develop, implement, and manage PV compliance frameworks, including SOPs, processes, and systems for program drug safety reporting.
• Work directly with cross-functional teams, including Patient Solutions, Pharmacy, Regulatory Affairs, and Clinical, to facilitate an integrated and patient-centered approach to PV compliance.
• Ensure PV systems are audit-ready, including preparing for and supporting regulatory authority inspections.
• Conduct regular assessments of PV risk management, identify and address compliance gaps, and recommend improvements in collaboration with QA and Patient Solutions.
• Monitor regulatory changes in PV and assess their impact on front-end operations, keeping stakeholders informed of updates and required actions.
• Oversee and assess quality performance of internal and external resources, regularly reporting to senior management.
• Support internal and external PV audits, including audits of business partners and service providers, ensuring findings are communicated and addressed.
• Contribute to the development and delivery of PV compliance training tailored to frontline and patient solutions teams.
• Facilitate the timely preparation and submission of regulatory filings related to PV, including safety reports and risk management plans.
• Assist in investigations of compliance breaches, implementing corrective and preventive actions (CAPAs) as needed.
• Actively engage in continuous improvement initiatives to enhance PV processes and ensure quality integration across all frontline operations.
• Upon notification of program enhancements, assist with developing associate training materials and participate in training sessions ensuring associates understand how the program enhancement will impact AE), product quality complaint (PQC), and medical inquiry (MI) handling and reporting to clients.
• Participate in source data verification for monthly PV QC as needed.
• Identify and report adverse events pursuant to program requirements
• Identify, document, and report safety information
• include interviewing; hiring; training; coaching/mentoring; planning, assigning, and directing work; appraising performance; professional development; disciplinary actions; addressing complaints; and resolving problems.

Qualifications

• Education: Bachelor’s degree in a scientific discipline (Pharmacy, Life Sciences, etc.) or equivalent experience required.
• Experience:7+ years of experience in pharmacovigilance/drug safety, with 3+ years in a compliance, oversight, or quality-driven role.
• Strong knowledge of global PV regulations, including ICH guidelines and GVP Modules.
• Experience with health authority inspections (e.g., DEA, State Board of Pharmacy, URAC and ACHC, OIG, etc.) and audit readiness.
• Experience in biopharmaceutical or biotechnology industries preferred
• Certification in pharmacovigilance, compliance, or related fields preferred
• Familiarity with PV databases and safety signal detection tools preferred
• Experience working with cross-functional teams, including patient-facing teams, with proven skills in stakeholder management.
• Proficiency in quality reporting tools and establishing performance metrics.
• Experience drafting and developing procedural documents and training programs.
• Strong organizational and leadership skills with a focus on front-end and patient-centered operations.
• Excellent collaboration and engagement skills, with the ability to drive cross-functional teamwork.
• Proven project management and problem-solving abilities.
• Detail-oriented, analytical, and capable of managing complex requirements in a fast-paced environment.
• Strong written and verbal communication skills.
• Demonstrates ability to identify, assess, and report adverse events

Pay Range

USD $111,300.00 - USD $139,125.00 /Yr.