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    Manager, Pharmacovigilance

    Icon
    5+ years
    Not Disclosed
    Chennai
    10 Dec. 17, 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: Manager, Pharmacovigilance
    Location: [Location]
    Date Posted: [Date]

    About the Role:
    ICON plc, a world-leading healthcare intelligence and clinical research organization, is looking for a Manager, Pharmacovigilance to join our innovative team. In this role, you will be responsible for overseeing and guiding direct reports, ensuring the successful monitoring and implementation of projects in alignment with company goals and profitability. This position offers the opportunity to shape the future of clinical development while working in a diverse, inclusive, and forward-thinking environment.

    Responsibilities:

    • Support direct reports in monitoring and meeting project goals and profitability objectives.
    • Develop, implement, and monitor profitability metrics and objectives for the assigned group.
    • Identify and implement process improvements by reviewing project-specific plans and recommending changes.
    • Manage resources and resource projections to ensure project teams meet client needs and contractual obligations.
    • Analyze project backlogs to ensure adequate resources are in place to meet business objectives.
    • Build and lead a technical team to perform key operating tasks and achieve project results.
    • Provide technical oversight for generating project plans such as Safety Management Plans (SMP) and SAE Reconciliation Plans.
    • Deliver training to Pharmacovigilance staff and other team members on relevant topics.
    • Collaborate with other functional managers to ensure safety management approaches align across the company.
    • Stay current with industry practices and regulatory requirements impacting services.
    • Review the work of team members in areas such as reporting and project management, ensuring quality service delivery to clients.
    • Foster a learning environment for staff development, mentorship, and career growth.
    • Contribute to business development efforts and maintain client relationships for repeat business.
    • Participate in proposal development and presentations for new business opportunities.
    • Manage vendor relationships, including pharmacovigilance vendors, and support audit preparation and responses.
    • Travel approximately 15% (domestic and/or international).

    Qualifications and Experience:

    • Extensive experience in pharmacovigilance and project management, preferably within the clinical research or healthcare industry.
    • Strong leadership and mentoring skills.
    • Experience in managing and optimizing project teams, ensuring goals are met efficiently.
    • Deep understanding of industry regulations, best practices, and safety management processes.
    • Excellent communication, organizational, and problem-solving skills.
    • Ability to thrive in a dynamic, fast-paced environment with changing priorities.

    What ICON Can Offer You:
    At ICON, we value the quality of our people and are committed to building a diverse and high-performing workforce. Along with a competitive salary, we offer a range of benefits to ensure well-being and work-life balance, including:

    • Various annual leave entitlements
    • Health insurance options to suit you and your family’s needs
    • Retirement planning offerings
    • Employee Assistance Programme (LifeWorks)
    • Life assurance and flexible country-specific optional benefits

    ICON’s Commitment to Diversity:
    ICON is proud to maintain an inclusive, diverse work environment, where all employees feel valued. We are an equal opportunity employer and are committed to ensuring equal treatment for all candidates and employees, regardless of background or identity.

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