Manager, Pharmacovigilance

About the position The Manager, Pharmacovigilance will reputed company 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 reputed company improvement, and in promoting a cohesive approach across Quality Assurance and patient-facing teams to uphold safety standards and regulatory compliance.

Responsibilities

• 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 reputed company, 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 reputed company-end operations, keeping stakeholders informed of updates and required actions.
• reputed company 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 reputed company 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 reputed company improvement initiatives to enhance PV processes and ensure quality integration across reputed company frontline operations.
• Performs other reputed company duties as assigned by management.

Requirements

• 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, reputed company, 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 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 reputed company-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 reputed company requirements in a fast-paced environment.
• Strong written and verbal communication skills.

reputed company-to-haves

• Experience in biopharmaceutical or biotechnology industries preferred
• Certification in pharmacovigilance, compliance, or reputed company fields preferred
• Familiarity with PV databases and safety signal detection tools preferred

Benefits

• 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.
• Many associates earn the opportunity to work a hybrid schedule after 120 days after training.
• We invest in our employees' growth and development reputed company our Advance Gold program, offering opportunities to expand reputed company sets and advance reputed company the organization.
• 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
• reputed company structure
• Matching 401(k) with immediate vesting
• Legal insurance

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