Manager, Pharmacovigilance
AssistRx
full-time
Posted on:
Location Type: Remote
Location: Florida • United States
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About the role
- 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.
Requirements
- 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.
Benefits
- Work Hard, Play Hard: Preloaded PTO: 100 hours (12.5 days) PTO upon employment, increasing to 140 hours (17.5 days) upon anniversary. Tenure vacation bonus: $1,000 upon 3-year anniversary and $2,500 upon 5-year anniversary.
- Impactful Work: Join a team that is at the forefront of revolutionizing healthcare by improving patient access to essential medications.
- Flexible Culture: Many associates earn the opportunity to work a hybrid schedule after 120 days after training. Enjoy a flexible and inclusive work culture that values work-life balance and diverse perspectives.
- Career Growth: We prioritize a “promote from within mentality”. We invest in our employees' growth and development via our Advance Gold program, offering opportunities to expand skill sets and advance within the organization.
- Innovation: Contribute to the development of groundbreaking solutions that address complex challenges in the healthcare industry.
- Collaborative Environment: Work alongside talented professionals who are dedicated to collaboration, learning, and pushing the boundaries of what's possible. ***Tell your friends about us! If hired, receive a $750 referral bonus!***
- Medical, dental, vision, life, & short-term disability insurance
- Teledoc services for those enrolled in medical insurance
- Supportive, progressive, fast-paced environment
- Competitive pay structure
- Matching 401(k) with immediate vesting
- Legal insurance
- #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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancedrug safetycompliancequality assurancerisk managementaudit readinessregulatory filingssafety signal detectionprocedural documentationperformance metrics
Soft Skills
organizational skillsleadership skillscollaboration skillsstakeholder managementproject managementproblem-solvinganalytical skillsdetail-orientedcommunication skillsteamwork
Certifications
pharmacovigilance certificationcompliance certification