Manager, Pharmacovigilance - Front End Operations

Role Overview

The Manager for Pharmacovigilance Front End Operations will oversee critical operational support activities ensuring compliance with global drug safety regulations. This position partners with Quality Assurance, Patient Solutions, and Compliance teams to maintain and enhance standards related to drug safety, reporting, risk management, and audit preparedness.

Key Responsibilities

• Lead execution of pharmacovigilance compliance efforts aligning with global regulations, including DEA, State Board of Pharmacy, URAC, ACHC, OIG, and other industry standards, with an emphasis on integrating efforts across Quality Assurance and Patient Solutions.
• Collaborate with Quality Assurance and Operations to establish, implement, and manage frameworks such as SOPs and processes for drug safety reporting.
• Work closely with cross-functional groups including Patient Solutions, Pharmacy, Regulatory Affairs, and Clinical to ensure a patient-centric, integrated approach.
• Maintain audit readiness of PV systems, orchestrate preparation and support during regulatory inspections.
• Regularly conduct PV risk assessments, identify compliance gaps, and suggest improvements in collaboration with relevant teams.
• Monitor changing regulatory requirements impacting front-end pharmacovigilance operations and communicate necessary updates to stakeholders.
• Oversee and evaluate quality performance of both internal and external resources; report findings to senior leadership.
• Support both internal and external audits, including third-party audits, ensuring corrective actions are communicated and followed.
• Contribute to the design and delivery of pharmacovigilance compliance training tailored to frontline and patient-facing teams.
• Ensure timely preparation and regulatory submission of safety reports and risk management plans.
• Investigate compliance breaches, initiate corrective and preventive actions as needed.
• Drive continuous improvement initiatives to enhance PV processes and integration with frontline operations.
• Perform supervisory duties in line with company policies and legal requirements, including hiring, training, coaching, performance evaluations, disciplinary actions, and problem resolution.

Candidate Requirements

• Bachelor’s degree in Pharmacy, Life Sciences, or related scientific field, or equivalent experience.
• Minimum 7 years experience in pharmacovigilance or drug safety, with at least 3 years focused on compliance, oversight, or quality-related roles.
• Deep understanding of global PV regulations, ICH guidelines, and GVP modules.
• Experience preparing for and participating in health authority inspections (DEA, State Board of Pharmacy, URAC, ACHC, OIG, etc.).
• Prior involvement in biopharmaceutical or biotechnology sectors is advantageous.
• Certifications in pharmacovigilance, compliance, or related areas preferred.
• Knowledge of PV databases and safety signal detection tools is a plus.
• Proven ability to successfully collaborate with multidisciplinary, patient-facing teams, and manage stakeholders effectively.
• Skilled in quality reporting tools and performance metric development.
• Experience writing and updating procedural documents and compliance training materials.
• Strong leadership capabilities focused on patient-centered operational functions.
• Superior collaboration, communication, problem-solving, project management, and organizational skills.
• Detail-oriented with the capacity to manage complex compliance requirements in a dynamic environment.

Compensation and Benefits

• Engaging, supportive, and fast-paced workplace culture.
• Competitive remuneration structure.
• 401(k) plan with immediate vesting and employer matching.
• Comprehensive benefits package including medical, dental, vision, life, and short-term disability insurance coverage.

Employee Recognition Programs

• #TransformingLives Honor: Quarterly peer-to-peer award celebrating extraordinary contributions transforming patients' lives.
• Values Award: Quarterly recognition for individuals exhibiting core values such as Excellence, Winning, Respect, Inspiration, and Teamwork.
• Vision Award: Annual accolade for those who exceed expectations in supporting the company’s mission to improve patient access to therapies.

Equal Opportunity and Employment Conditions

The employer is an Equal Opportunity Employer committed to nondiscrimination based on race, religion, gender identity, sexual orientation, parental status, age, disability, and other protected factors under law.

Employment offers are contingent upon successful background checks.

Compliance with federal regulations requires all hires to verify identity and work eligibility in the U.S. Sponsorship or work authorization assistance is not available for this role.

The company does not accept unsolicited resumes from third-party agencies. Any such submissions become company property without any fee obligations.