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Manager, Pharmacovigliance

3+ years
Not Disclosed
10 Oct. 29, 2024
Job Description
Job Type: Full Time Remote 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

Company Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. We take pride in fostering an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development.

Job Summary:
As a Senior Pharmacovigilance Project Manager, you will manage personnel within Pharmacovigilance, providing expertise in Serious Adverse Events (SAE) management, periodic safety reports, and regulatory compliance. You will support departmental initiatives, develop SOPs, and maintain familiarity with current industry practices and regulations.

Key Responsibilities:

  • Support direct reports in monitoring projects to ensure profitability and achievement of objectives.
  • Develop, implement, and monitor profitability metrics for your team.
  • Identify and implement process improvements to enhance efficiency.
  • Manage resources to align with client needs and contractual obligations.
  • Analyze project backlog to ensure adequate resource allocation.
  • Build and align a technical team to achieve operational goals.
  • Provide technical oversight for project plans, such as Safety Management Plans.
  • Deliver training on departmental topics and company processes to staff.
  • Liaise with functional managers to ensure consistency in safety management approaches.
  • Review and lead project tasks for Pharmacovigilance staff, ensuring compliance with QMS and SOPs.
  • Foster a learning environment for staff development and career growth.
  • Participate in recruitment processes and business development initiatives.
  • Engage with clients and maintain relationships for repeat business.
  • Support audit preparation and respond to findings as needed.
  • Manage vendor relationships and assist the Qualified Person for Pharmacovigilance as required.

Qualifications:

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

What ICON Can Offer You:
Our success relies on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits, including:

  • Various annual leave entitlements.
  • Comprehensive health insurance options for you and your family.
  • Competitive retirement planning offerings.
  • Global Employee Assistance Programme providing 24/7 support.
  • Life assurance and flexible country-specific benefits.

At ICON, diversity, inclusion, and belonging are fundamental to our culture. We are committed to providing an inclusive and accessible environment for all candidates. We welcome applications from individuals of all backgrounds, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you need reasonable accommodation during the application process due to a medical condition or disability, please let us know.

Interested in the role?
Even if you’re unsure if you meet all the requirements, we encourage you to apply! You might be exactly what we’re looking for, whether for this position or others at ICON.