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Manager, Pharmacovigilance

3+ years
Not Disclosed
10 Nov. 21, 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 Title: Pharmacovigilance Manager - Office-Based, Bulgaria

Company: ICON plc

Location: Bulgaria

Job Overview:
ICON plc is a leading global healthcare intelligence and clinical research organization, focused on accelerating the development of life-saving drugs and medical devices. We are currently seeking a Pharmacovigilance Manager to lead our pharmacovigilance team, ensuring regulatory compliance and operational excellence across various projects. As a manager, you will oversee project profitability, improve processes, and ensure your team’s success within ICON’s safety management framework.

Key Responsibilities:

  • Project and Resource Management: Ensure profitability, manage project goals, objectives, and metrics for direct reports. Monitor project timelines, resource needs, and client expectations to meet business objectives.
  • Process Improvement: Identify areas of improvement in processes and workflows within pharmacovigilance services. Implement strategies for better efficiency and ensure timely, high-quality delivery.
  • Team Leadership: Build, develop, and lead a team to perform critical operational tasks. Provide technical oversight, mentorship, and career development opportunities.
  • Safety Reporting: Oversee and ensure that safety reporting processes are consistent and compliant with both internal and external standards, including timelines for SAE management and periodic safety reports.
  • Training and Development: Develop and deliver training programs to enhance team performance and ensure that all staff members are equipped with up-to-date industry knowledge.
  • Client and Business Development: Maintain strong client relationships and support business development initiatives, including proposal development, presentations, and new business opportunities.
  • Audits and Compliance: Support audit preparation, conduct audits, and address audit findings. Ensure adherence to internal and regulatory standards for pharmacovigilance processes.
  • Vendor Management: Oversee vendor relationships, ensuring they meet project expectations and timelines.
  • SOP and Process Development: Support the creation and refinement of Standard Operating Procedures (SOPs) to ensure best practices are followed across the organization.

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, with a broad understanding of clinical development and safety requirements.
  • Leadership Skills: Strong leadership and project management abilities with a proven track record of managing diverse and globally distributed teams.
  • Analytical Skills: Strong analytical mindset to monitor performance and implement process improvements.
  • Language Skills: Excellent command of English (both written and spoken).

Benefits of Working at ICON:

ICON offers a competitive salary and a comprehensive range of benefits, including:

  • Annual Leave: Generous leave entitlements.
  • Health Insurance: Tailored health insurance options for you and your family.
  • Retirement Planning: Competitive retirement planning offerings.
  • Employee Assistance Program: LifeWorks, offering global access to a network of support professionals.
  • Other Benefits: Life assurance, flexible benefits (childcare, gym memberships, etc.), and more.

Why ICON?

At ICON, diversity, inclusion, and belonging are central to our values. Our diverse workforce fosters creativity, helping us better serve clients and communities. We are committed to providing an inclusive environment free of discrimination and harassment.