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Manager, Pharmacovigilance

5+ years
Not Disclosed
10 Dec. 16, 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

Job Title: Manager, Pharmacovigilance- Systems
Category: Healthcare/Clinical Research
Location: [Location not mentioned in the description]
Experience: [Experience not explicitly mentioned, but relevant background in pharmacovigilance and systems management is needed]
Openings: [Number not specified]


Job Description Summary:

ICON plc, a global leader in healthcare intelligence and clinical research, is looking for a Safety Technology Lead (STL) for the Pharmacovigilance Systems & Safety Reporting Group (PVSS/SRG). The primary role of this position is to be the global point of contact for ICON Safety Systems and provide expertise and support for the Argus and Safety Reporting System (SRS) user community.

As an STL, you will play a critical role in managing PV projects, ensuring audit readiness, supporting database setup, migration, and testing, and serving as a mentor for systems staff. You will also be responsible for guiding User Acceptance Testing, liaising with vendors, and assisting with project budgets and resourcing activities.

Key Responsibilities:

  • Serve as a global point of contact for ICON Safety Systems.
  • Provide expertise in Argus and Safety Reporting Systems (SRS) to internal and external users.
  • Gather and document user requirements for ongoing PV systems projects.
  • Assist in database setup, testing, maintenance, and migrations for safety systems.
  • Ensure successful project completion within budget and on time, meeting quality levels.
  • Collaborate with the IT team and other departments to implement system and process improvements.
  • Act as the main contact for clients throughout the lifecycle of assigned systems projects.
  • Ensure compliance with ICON standards, regulatory requirements, and sponsor processes.
  • Maintain project budgets, timelines, and manage out-of-scope activities.

What ICON Can Offer You:

  • Competitive salary and a comprehensive benefits package.
  • Health insurance, retirement planning options, and global employee assistance programs.
  • Opportunities for work-life balance, personal well-being, and career development.
  • Flexible country-specific benefits including childcare vouchers, gym memberships, and more.

At ICON, we are committed to diversity, inclusion, and belonging. We celebrate diverse perspectives and foster a culture of innovation and excellence.


How to Apply:

  • [Insert link to application]
  • Note: ICON encourages applicants to apply even if they do not meet all the listed requirements.