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Manager, Pharmacovigilance

3+ years
Not Disclosed
10 Nov. 20, 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

Pharmacovigilance Manager – Office-Based, Sofia, Bulgaria

ICON plc is a global leader in healthcare intelligence and clinical research, committed to innovation, excellence, and diversity. We are seeking a dedicated Pharmacovigilance Manager to join our team and contribute to shaping the future of clinical development.

Job Summary:

As a Pharmacovigilance Manager, you will lead and manage a team within Pharmacovigilance, ensuring regulatory compliance, and optimal operational efficiency in safety reporting and adverse event management. Your role will involve overseeing processes related to Serious Adverse Events (SAE), periodic safety reports, product complaints, and ensuring high-quality outcomes in line with client and regulatory expectations.

Key Responsibilities:

  • Team Management: Lead and support a diverse team, ensuring fulfillment of responsibilities in accordance with ICON policies, procedures, and SOPs.
  • Process Improvement: Identify and implement process improvements for service delivery, enhance efficiency, and ensure project goals are met.
  • Project Oversight: Develop and monitor profitability, metrics, and resource management to ensure project objectives align with client needs.
  • Training & Development: Deliver training to staff, ensure continuous learning, career development, and high-quality performance within the team.
  • Client Engagement: Interact with clients, participate in meetings, and support business development efforts to foster new and existing relationships.
  • Compliance & Reporting: Ensure timely submission of safety reports, documentation, and handle audit preparations as required.
  • Leadership: Provide technical oversight on safety management plans and contribute to business development initiatives.

Requirements:

  • Education: Bachelor’s degree or higher in a healthcare-related or life science field.
  • Experience: Minimum of 3 years of experience as a Pharmacovigilance Manager within a CRO or BPO.
  • Skills: Strong leadership, project management, analytical mindset, and in-depth knowledge of clinical development and pharmacovigilance.
  • Language: Fluent in English.

Why ICON?

At ICON, we value our people and foster a culture of continuous learning and development. Our benefits package includes competitive salaries, health insurance, retirement planning, and work-life balance initiatives.

ICON is an equal opportunity employer committed to diversity and inclusion. We provide an accessible and inclusive environment for all candidates and employees.

If you're passionate about leading high-performing teams and driving excellence in pharmacovigilance, apply today to join us in shaping the future of clinical development.