AssistRx · 11 hours ago
Manager, Pharmacovigilance
Orlando, FL
Full-time
Hybrid
Senior Level
7+ years expAssistRx is a growing organization that provides life sciences companies with efficient solutions to improve patient outcomes. The Manager, Pharmacovigilance will lead operational support for pharmacovigilance activities, ensuring compliance with global regulatory requirements and promoting a cohesive approach across teams to uphold safety standards.
HealthcareInformation TechnologyHealth Care
No H1B
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
Performs other related duties as assigned by management
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
Responsibilities include interviewing; hiring; training; coaching/mentoring; planning, assigning, and directing work; appraising performance; professional development; disciplinary actions; addressing complaints; and resolving problems
Qualification
Required
Bachelor's degree in a scientific discipline (Pharmacy, Life Sciences, etc.) or equivalent experience required
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 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
Preferred
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
Benefits
Medical, dental, vision, life, & short-term disability insurance
Teledoc services for those enrolled in medical insurance
Competitive pay structure
Matching 401(k) with immediate vesting
Legal insurance
Company
AssistRx
AssistRx, Inc provides healthcare information technology solutions to the Specialty Pharmaceutical distribution channel.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-02-22Acquired
Leadership Team
Edward Hensley
Co-Founder & Chief Commercial Officer
Adam Dresen
Chief Technology Officer | CISO
Recent News
2025-09-30
Company data provided by crunchbase