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 Now
Apply Now
• 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 Now
Apply Now