Manager, Pharmacovigilance

RXinsider LTD.; Town of Florida (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

AssistRx, Inc. is seeking a Manager, Pharmacovigilance – Front End Operations to lead frontline PV compliance activities and align drug safety practices with global regulatory standards.

The role interfaces with QA, Patient Solutions, and Compliance to drive audit readiness and proactive risk management. With 7+ years in PV and 3+ years in a compliance-oriented role, you will develop frameworks, SOPs, and training programs, while ensuring effective collaboration across regulatory, clinical, and

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience.
• 7+ years in pharmacovigilance/drug safety, with 3+ years in a compliance/quality role.
• Strong knowledge of global PV regulations (ICH, GVP).
• Experience with health authority inspections and audit readiness.
• Experience in biopharma/biotech industries preferred.
• Certification in pharmacovigilance or related fields preferred.
• Familiarity with PV databases and signal detection tools.
• Experience drafting procedural documents and training programs.
• Proven project management and leadership abilities.

Responsibilities

• Lead PV compliance activities to meet global regulatory requirements.
• Develop and manage PV compliance frameworks, SOPs, processes, and systems.
• Collaborate with cross-functional teams to integrate PV compliance with QA and Patient Solutions.
• Ensure PV systems are audit-ready and support regulatory inspections.
• Monitor PV risk management and address compliance gaps with QA.
• Oversee PV audits and communicate findings.
• Deliver PV compliance training for frontline teams.
• Prepare regulatory filings related to PV and risk management.

Skills

Pharmacovigilance experience

GVP knowledge

Regulatory inspections

PV databases

CAPA management

Leadership

Training programs

Quality metrics

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in scientific discipline

Tools

PV software

Job description

The Manager, Pharmacovigilance - Front End Operations will lead frontline operational support for pharmacovigilance (PV) activities, directly interfacing with Quality Assurance, Patient Solutions, and Compliance to ensure consistent alignment with global regulatory requirements for drug safety, reporting, and risk management. This role is instrumental in establishing and maintaining frameworks for audit readiness, proactive monitoring, and continuous improvement, and in promoting a cohesive approach across Quality Assurance and patient-facing teams to uphold safety standards and regulatory compliance.

• 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

Requirements

• Education: 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 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

Benefits

• Supportive, progressive, fast-paced environment
• Competitive pay structure
• Matching 401(k) with immediate vesting
• Medical, dental, vision, life, & short-term disability insurance

Wondering how we recognize our employees for delivering best in class results? Here are some of the awards that our employees receive throughout the year!

• #TransformingLives Honor: This quarterly award program is a peer to peer honor that recognizes and highlights some of the amazing ways that our team members are transforming lives for patients on a daily basis
• Values Award: This quarterly award program recognizes individuals who exhibit one, or many, of our core company values; Excellence, Winning, Respect, Inspiration, and Teamwork
• Vision Award: This annual award program recognizes an individual who has gone above and beyond to support the AssistRx vision to transform lives through access to therapy

AssistRx, Inc. is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service, or other non-merit based factors, or any other protected categories protected by federal, state, or local laws.

All offers of employment with AssistRx are conditional based on the successful completion of a pre-employment background check.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Sponsorship and/or work authorization is not available for this position.

AssistRx does not accept unsolicited resumes from search firms or any other vendor services. Any unsolicited resumes will be considered property of AssistRx and no fee will be paid in the event of a hire.