Manager, Pharmacovigilance

Job Description:

• 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.

Apply tot his job Apply To this Job