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Manager, Pharmacovigliance

5+ years
Not Disclosed
10 Oct. 29, 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

Job Opportunity: Senior Pharmacovigilance Project Manager

Company: ICON plc
Location: [Insert Location]
Job Type: [Insert Job Type]

Company Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are committed to fostering an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development and enhance patient outcomes.

Job Summary

The Senior Pharmacovigilance Project Manager is responsible for managing personnel within the Pharmacovigilance team, providing expertise in Serious Adverse Events (SAE) management, periodic safety reports, and regulatory compliance. You will support departmental initiatives, develop SOPs, and ensure that all staff fulfill their responsibilities in accordance with company policies and regulatory requirements.

Key Responsibilities

  • Monitor projects to ensure profitability and that goals are met.
  • Develop, implement, and track objectives and metrics for direct reports.
  • Identify and implement process improvements within assigned services.
  • Manage resources to meet client expectations and contractual obligations.
  • Analyze project backlog to allocate resources effectively.
  • Build and lead a technical team to achieve project results.
  • Provide technical oversight for project plans, including Safety Management Plans and SAE Reconciliation Plans.
  • Deliver training on relevant topics and ensure consistency in safety management approaches across the company.
  • Review project tasks of team members and provide leadership in service delivery.
  • Foster an environment for learning, self-improvement, and career development.
  • Support business development initiatives and maintain existing client relationships.
  • Participate in client meetings and audit preparations.
  • Manage vendor relationships as necessary.
  • Support the Qualified Person for Pharmacovigilance as needed.

To Be Successful, You Will Need:

  • Bachelor’s degree (or higher) in a healthcare-related or life science field.
  • Minimum of 3 years’ experience as a Pharmacovigilance manager within a CRO or BPO.
  • Broad knowledge of clinical development and safety requirements from pre-clinical to post-marketing phases.
  • Strong leadership skills with experience managing a diverse, global team.
  • Excellent project management and analytical skills.
  • Proficient command of English.

What ICON Can Offer You

At ICON, our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. Our benefits include:

  • Competitive salary and performance-based incentives.
  • Various annual leave entitlements and health insurance options.
  • Retirement planning offerings for long-term savings.
  • Access to a global Employee Assistance Programme.
  • Flexible benefits tailored to your needs, including childcare vouchers and gym memberships.

Commitment to Diversity

ICON is an equal opportunity employer committed to diversity and inclusion. We strive to provide a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require accommodations during the application process due to a medical condition or disability, please let us know.