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Manager, Pharmacovigilance

3+ years
Not Disclosed
10 Oct. 24, 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

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We have an incredible opportunity for a Manager, Pharmacovigilance (Reporting Group) to join the team.

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

Job Summary

As the Manager of Pharmacovigilance, you will manage personnel within the Pharmacovigilance team and provide expertise on tasks related to Serious Adverse Events (SAE), Adverse Reactions, Medical Device Report management, periodic safety reports, and more. You will support departmental initiatives, the development of SOPs, and ensure compliance with regulatory requirements while maintaining familiarity with current industry practices.

Responsibilities

  • Support direct reports in project monitoring to ensure profitability and project goals are met.
  • Develop, implement, and monitor profitability metrics for your team.
  • Identify and implement process improvements to enhance efficiency within the service area.
  • Manage resource allocation to align with client needs and contractual obligations.
  • Analyze project backlogs to ensure adequate resource provision.
  • Build and align a technical team to achieve operational results.
  • Provide technical oversight during project plan generation and training for staff.
  • Liaise with other functional managers for consistency in safety management.
  • Ensure staff compliance with company and client QMS, policies, and SOPs.
  • Foster an environment of learning and career development for staff.
  • Participate in recruiting processes for new team members.
  • Interact with clients to maintain and support new business opportunities.
  • Prepare for audits and respond to findings as necessary.
  • Manage vendor relationships and support the Qualified Person for Pharmacovigilance as required.

To be successful you will need:

  • Bachelor’s degree (or higher) in a healthcare-related or life science field.
  • A minimum of 3 years’ experience as a Pharmacovigilance manager within a CRO or BPO.
  • Broad knowledge of clinical development and safety requirements from pre-clinical to post-marketing.
  • Strong leadership skills with a track record of managing diverse, globally distributed teams.
  • Excellent project management and analytical skills.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of benefits designed to support well-being and work-life balance for you and your family, including:

  • Various annual leave entitlements
  • Comprehensive health insurance options
  • Competitive retirement planning offerings
  • Global Employee Assistance Programme (LifeWorks)
  • Flexible country-specific benefits, such as childcare vouchers and discounted gym memberships

Visit our careers site to read more about the benefits ICON offers.

ICON is an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment.

If you need a reasonable accommodation for the application process or to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all the requirements? We encourage you to apply—there’s a chance you’re exactly what we’re looking for!

Are you a current ICON Employee? Please click here to apply.