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Pharmacovigilance Associate

1+ years
Not Disclosed
10 Jan. 13, 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

Job Title: Pharmacovigilance Associate
Location: Hybrid (2 days per week on-site)

About the Role:

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, government, and public health organizations. With our patients at the center of everything we do, we help accelerate the development of drugs and devices that save lives and improve the quality of life.

At ICON, our people are our greatest strength, driving our success with a passion to succeed and a commitment to excellence.

Role Purpose:

The ICON Pharmacovigilance Associate will perform a range of activities related to adverse event collection, processing, and reporting for the client's Global Patient Safety Team.

Key Responsibilities:

  • Perform tasks within the assigned functional area, ensuring proficiency to meet delivery targets and client expectations.
  • Understand and apply documented processes and conventions related to assigned activities.
  • Develop an understanding of legislative requirements for pharmacovigilance activities.
  • Deliver high-quality work in line with compliance standards, avoiding late reporting and non-compliance. Contribute to investigations for corrective and preventative actions.
  • Support inspection readiness and understand audit/inspection processes.
  • Ensure awareness of Business Continuity Plans and when they should be implemented.
  • Core team tasks may include receipt, triage, and initial data entry of Individual Case Safety Reports (ICSRs), expedited and aggregate safety reporting, and maintaining EMA master data repositories.

Required Competencies:

  • Clear and effective verbal and written communication skills.
  • Proven ability to prioritize and meet deadlines while managing multiple tasks.
  • Ability to escalate issues effectively and propose solutions.
  • Strong decision-making based on experience and awareness of authority limits.
  • Ability to build and maintain relationships within the team to work collaboratively.
  • Proficiency in receiving and acting on feedback constructively.
  • Strong understanding of confidentiality and the ability to protect company information.

Minimum Qualifications:

  • Fluent in English with effective communication skills (written and verbal).
  • Proficient in Microsoft Office Suite.
  • Knowledge of medical terminology.
  • Excellent organizational and time management skills.
  • Detail-oriented with a strong ability to prioritize tasks.

Preferred Qualifications:

  • 1+ year of relevant experience in the clinical industry.
  • Knowledge of global pharmacovigilance regulations.
  • Familiarity with medical coding systems.
  • Ability to work autonomously and influence without authority.
  • Flexibility to adapt to changing priorities in a fast-paced environment.
  • Strong interpersonal skills with the ability to provide and apply constructive feedback.

Benefits of Working at ICON:

At ICON, our success depends on the capabilities and quality of our people. We are committed to fostering a continuous learning culture and providing opportunities for professional development. Our comprehensive total rewards package includes:

  • Competitive base pay and variable pay programs.
  • Best-in-class employee benefits and well-being initiatives tailored to support you and your family.
  • Supportive policies and career development opportunities.

Equal Opportunity Employer:

ICON is an equal opportunity and inclusive employer, committed to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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