Instagram
youtube
Facebook

Pharmacovigilance Reporting Specialist

2+ years
Not Disclosed
10 Oct. 29, 2024
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

Company Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. We pride ourselves on fostering an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development.

From molecule to medicine, we advance clinical research, providing outsourced services to pharmaceutical, biotechnology, medical device, and public health organizations. With patients at the center of everything we do, we help accelerate the development of life-saving drugs and devices.

Our people are our greatest strength, driving our culture and success. At ICON, we are committed to succeeding with passion and excellence.

Key Responsibilities:

  • Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and safety information to clients, regulatory authorities, ethics committees, investigators, and third-party vendors within specified timelines.
  • Release safety reporting intelligence for expedited and periodic reports in accordance with company procedures.
  • Provide in-depth expertise on safety reporting processes and maintain a comprehensive understanding of ICON’s safety reporting systems and SOPs.
  • Oversee assigned projects to ensure all ICON, sponsor, and regulatory timeframes are met for safety information reporting.
  • Ensure accuracy and compliance of all project activities with ICON standards, regulatory requirements, and client obligations.
  • Support the Safety Reporting Group management in departmental activities, including quality metrics review, finance tracking, project resource tracking, and training oversight.
  • Collaborate with project team members, client contacts, investigators, and vendors to build and maintain strong relationships.
  • Maintain project information in multiple databases and ensure timely updates.
  • Perform quality control and filing of documents submitted to the eTMF or agreed filing solution for audits and inspections.
  • Assist in developing departmental SOPs and working procedures.

Requirements:

  • Bachelor's degree in life sciences.
  • 4 to 6 years of experience in a similar pharmacovigilance role.
  • Fluency in English.

Benefits of Working at ICON: Our success depends on the knowledge, capabilities, and quality of our people. We are committed to continuous learning, providing a comprehensive total rewards package that includes:

  • Competitive base pay and variable pay recognition programs.
  • A wide range of health insurance options for you and your family.
  • Retirement planning offerings to maximize savings for the future.
  • Access to a Global Employee Assistance Program, LifeWorks, providing 24/7 support for your well-being.
  • Flexible benefits, including childcare vouchers, discounted gym memberships, and more.

At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We are proud of our diverse workforce and are dedicated to providing an inclusive environment for all candidates. We are committed to ensuring a workplace free of discrimination and harassment.

If you require reasonable accommodation during the application process or in performing essential job functions due to a medical condition or disability, please let us know.

Interested in the role?
Even if you’re unsure if you meet all the requirements, we encourage you to apply! You might be exactly what we’re looking for, whether for this position or others at ICON.