Job Description
Job Description
Job Description
The Manager, Pharmacovigilance - Front End Operations will lead 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 continuous improvement, and in promoting a cohesive approach across Quality Assurance and patient-facing teams to uphold safety standards and regulatory compliance.
Requirements
- 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.
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
- Responsibilities include interviewing; hiring; training; coaching/mentoring; planning, assigning, and directing work; appraising performance; professional development; disciplinary actions; addressing complaints; and resolving problems.
Benefits
- Education: 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, 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.
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