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Senior Manager, Pharmacovigilance

5+ years
Not Disclosed
10 Aug. 23, 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, WHO DD Coding

Position: Senior Manager, Pharmacovigilance

Location: Mexico City, Mexico (Office-based with remote flexibility)

Company Overview:

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 shaping the future of clinical development and be a part of our mission to advance healthcare.

Role Overview:

We are seeking a Senior Manager, Pharmacovigilance to lead our Reporting Group. This role involves managing personnel, overseeing pharmacovigilance tasks such as Serious Adverse Events (SAE) and Adverse Reactions management, and ensuring compliance with industry standards. You will support departmental initiatives, SOP development, and regulatory compliance while maintaining familiarity with current industry practices.

Key Responsibilities:

  • Project Management: Monitor projects to ensure profitability and adherence to goals. Serve as the primary contact for the lifecycle of stand-alone and full-service projects, ensuring client needs and contractual obligations are met.

  • Team Leadership: Develop and manage a technical team, providing oversight and training. Foster an environment that encourages learning and career development. Conduct performance reviews and succession planning.

  • Process Improvement: Identify and implement process improvements within your service area. Recommend and oversee changes to enhance efficiency and effectiveness.

  • Resource Management: Analyze project backlogs and manage resources to align with business objectives. Ensure that project teams are appropriately staffed and meet client expectations.

  • Client and Stakeholder Interaction: Act as the main pharmacovigilance contact for clients, participate in client meetings, and support business development initiatives, including presentations and proposal development.

  • Compliance and Quality Assurance: Ensure staff comply with company policies, procedures, and SOPs. Prepare for and support audits, respond to findings, and manage vendor relationships.

  • Training and Development: Deliver training on pharmacovigilance topics and general company processes. Support the development and implementation of training programs for pharmacovigilance staff.

  • Additional Duties: Oversee literature search activities and ensure project deliverables are met. Support revenue forecasting and business development for literature projects. May serve as Local/Qualified Person for Pharmacovigilance.

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.
  • Skills: Strong leadership and project management skills with a proven track record of managing diverse, globally distributed teams. Analytical mindset and familiarity with clinical development and safety requirements.
  • Languages: Fluency in Japanese is a plus.

What ICON Offers:

  • Competitive salary and a range of benefits designed to support your well-being and work-life balance.
  • Health insurance options, retirement planning, and various leave entitlements.
  • Access to a global Employee Assistance Programme, LifeWorks, providing 24-hour support.
  • Flexible, country-specific benefits including childcare vouchers, gym memberships, and travel passes.

ICON is an equal opportunity and inclusive employer. We provide a workplace free of discrimination and harassment, and we are committed to ensuring all qualified applicants receive equal consideration for employment.

Interested in Applying?

If you meet the qualifications and are interested in this role, we encourage you to apply. Even if you’re unsure about meeting all the requirements, you may be the perfect fit for this or other opportunities at ICON.

Current ICON Employees:

If you are a current ICON employee, please click here to apply.

For accommodations due to medical conditions or disabilities, please let us know or submit a request here.