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Manager, Pharmacovigilance (Remote)

7+ years
Not Disclosed
10 Nov. 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager, Pharmacovigilance - Front End Operations

Description: The Manager, Pharmacovigilance - Front End Operations will lead operational support for pharmacovigilance (PV) activities, collaborating with Quality Assurance, Patient Solutions, and Compliance teams to ensure alignment with global regulatory requirements for drug safety, reporting, and risk management. This role will be responsible for creating and maintaining frameworks for audit readiness, proactive monitoring, and continuous improvement while fostering a collaborative approach to uphold safety standards and regulatory compliance across teams.

Responsibilities:

  • Drive PV compliance activities to meet global regulatory requirements (e.g., DEA, State Board of Pharmacy, URAC, ACHC, OIG) and industry standards.
  • Partner with Quality Assurance and Operations to develop and manage PV compliance frameworks, including SOPs, processes, and systems for drug safety reporting.
  • Collaborate with cross-functional teams (Patient Solutions, Pharmacy, Regulatory Affairs, Clinical) to integrate PV compliance into patient-centered operations.
  • Ensure PV systems remain audit-ready, supporting regulatory inspections and assessments.
  • Conduct regular PV risk management assessments and address compliance gaps with QA and Patient Solutions.
  • Monitor regulatory changes in PV, updating stakeholders on necessary actions.
  • Oversee the quality performance of internal and external resources, reporting to senior management.
  • Support internal and external PV audits, addressing findings and ensuring resolution.
  • Contribute to developing and delivering PV compliance training to frontline teams.
  • Assist in the preparation and submission of regulatory filings related to PV, such as safety reports and risk management plans.
  • Investigate compliance breaches and implement corrective and preventive actions (CAPAs).
  • Engage in continuous improvement initiatives to enhance PV processes and ensure integration across frontline operations.
  • Carry out supervisory responsibilities, including hiring, training, performance management, and employee development.

Requirements:

  • Bachelor’s degree in a scientific discipline (Pharmacy, Life Sciences, etc.) or equivalent experience.
  • 7+ years of experience in pharmacovigilance/drug safety, with 3+ years in a compliance or quality-driven role.
  • Strong knowledge of global PV regulations, including ICH guidelines and GVP Modules.
  • Experience with health authority inspections (DEA, State Board of Pharmacy, URAC, ACHC, OIG).
  • Preferred experience in biopharmaceutical or biotechnology industries.
  • Certification in pharmacovigilance or compliance preferred.
  • Familiarity with PV databases and safety signal detection tools.
  • Proven experience in stakeholder management and cross-functional team collaboration.
  • Proficiency in quality reporting tools and performance metrics.
  • Strong organizational, leadership, and project management skills.
  • Excellent written and verbal communication skills.