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Pharmacovigilance Reporting Associate

0-2 years
Not Disclosed
10 Jan. 8, 2025
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

Title: Pharmacovigilance Reporting Associate

Location: [Location specifics]

About the Role:
ICON plc, a leading global healthcare intelligence and clinical research organization, is looking to expand its team with a passionate Pharmacovigilance Reporting Associate. As part of our mission to shape the future of clinical development, this role involves working on critical safety reporting tasks, ensuring compliance with regulatory standards, and fostering strong collaborations with cross-functional teams. If you’re eager to contribute to advancing global health while working in a dynamic and inclusive environment, this is the perfect opportunity for you.

Key Responsibilities:

  • Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and safety data to clients, regulatory authorities, ethics committees, and other stakeholders in line with project timelines.
  • Ensure timely release of safety reporting intelligence for expedited and periodic reports to regulatory bodies and investigators.
  • Maintain a strong understanding of ICON’s safety reporting systems, SOPs, and working procedures.
  • Oversee project safety reporting activities, ensuring compliance with regulatory and client requirements.
  • Serve as the lead for safety reporting, taking ownership of activities and ensuring accuracy and completeness.
  • Maintain project information, pharmacovigilance intelligence, and databases with regular updates.
  • Prepare for audits, represent the department in client and investigator meetings, and ensure readiness for inspections.
  • Provide mentorship and guidance to less experienced associates, supporting their development in safety reporting practices.
  • Collaborate with internal and external teams, building strong working relationships.
  • Review and implement updated safety reporting regulations and practices.
  • Travel (up to 10%) for domestic and/or international needs as required.

What ICON Can Offer You:

  • A diverse and inclusive work culture that celebrates high performance and nurtures talent.
  • Competitive salary along with additional benefits including:
    • Flexible annual leave entitlements.
    • Comprehensive health insurance options tailored to your needs.
    • Competitive retirement planning offerings.
    • Access to a global network of professionals through TELUS Health’s Employee Assistance Programme.
    • Life assurance and flexible benefits like childcare vouchers, gym discounts, and more.

Why Join ICON?
At ICON, diversity, inclusion, and belonging are integral to our values. We believe our diversity drives innovation, helping us better serve our clients, patients, and communities. We’re committed to offering an inclusive and accessible environment for all candidates.

Interested?
If you are interested in the role but feel unsure if you meet all the requirements, we encourage you to apply! We believe you might be exactly what we need here at ICON, whether for this or other roles.

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