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Senior Manager, Pharmacovigilance

8+ years
Not Disclosed
10 Aug. 22, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Senior Manager, Pharmacovigilance - Mexico City, Mexico (Hybrid: Office/Remote)

About ICON plc:

ICON plc is a global leader in healthcare intelligence and clinical research. 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 make a significant impact on patient care.

Role Overview:

We are seeking a Senior Manager, Pharmacovigilance to join our team in Mexico City. This role involves managing personnel within the Pharmacovigilance Reporting Group, overseeing serious adverse events (SAEs), adverse reactions, medical device report management, and more. The Senior Manager will support departmental initiatives, the development of SOPs, and ensure compliance with industry regulations.

Key Responsibilities:

  • Project Management: Monitor projects to ensure profitability, adherence to project goals, and timely completion. Serve as the main point of contact for customers throughout the project lifecycle, including stand-alone safety and medical information projects.

  • Team Leadership: Develop and implement objectives and metrics for your team. Manage resources to align with client needs and contractual obligations. Build and lead a technical team to achieve project results.

  • Process Improvement: Identify and implement process improvements to enhance efficiency and effectiveness. Review and recommend improvements to SOPs and project plans.

  • Training & Development: Deliver training on department-related topics and company processes. Foster staff development through mentorship and career growth opportunities. Ensure high-quality work performance and prepare staff for succession planning.

  • Client & Business Development: Interact with clients to support and maintain business relationships. Participate in business development initiatives and proposal development.

  • Compliance & Quality Assurance: Ensure compliance with company policies, procedures, and regulatory requirements. Prepare for and support audits and inspections. Manage vendor relationships and oversee call center handling teams as needed.

  • Documentation & Reporting: Prepare standard response letters, conduct literature searches, and oversee literature project setup and management.

Qualifications:

  • Education: Bachelor’s degree (or higher) in a healthcare-related or life science field.

  • Experience: Minimum of 8 years of senior-level experience in Pharmacovigilance within a CRO or BPO environment. Broad knowledge of clinical development and safety requirements from pre-clinical to post-marketing.

  • Skills: Strong leadership and project management skills, with a proven track record of managing and leading diverse, globally distributed teams. Analytical mindset with excellent communication skills. Fluency in Japanese is an advantage.

What ICON Offers:

  • Competitive Salary: Alongside your salary, ICON provides a comprehensive benefits package designed to support your well-being and work-life balance.

  • Benefits Include:

    • Various annual leave entitlements
    • Health insurance options tailored to you and your family
    • Competitive retirement planning offerings
    • Global Employee Assistance Programme (LifeWorks) providing 24-hour support
    • Life assurance
    • Flexible, country-specific benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, and health assessments

Equal Opportunity Employer:

ICON is committed to providing a workplace free of discrimination and harassment. We welcome all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require accommodations due to a medical condition or disability, please let us know or submit a request here.

Not Sure If You Meet All the Requirements?

We encourage you to apply even if you're unsure whether you meet every requirement. You might be exactly what we’re looking for at ICON, whether for this role or another opportunity.

Apply Today to Join Our Team!