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Pharmacovigilance Reporting Associate

0-2 years
Not Disclosed
10 May 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 Reporting Associate


Company:

ICON Plc
ICON plc is a world-leading healthcare intelligence and clinical research organization, fostering an inclusive environment focused on innovation and excellence. ICON is committed to shaping the future of clinical development.


Location:

India (Homeworking)


Salary:

Competitive


Start Date:

1 May 2025


Closing Date:

2 May 2025


Job Description / Responsibilities:

As a Pharmacovigilance Reporting Associate at ICON, you will be responsible for ensuring accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. Your duties will include:

  • Preparing and reviewing safety reports, including periodic safety updates and individual case safety reports, ensuring compliance with regulatory standards.

  • Collecting and analyzing adverse event data from clinical trials and post-marketing sources.

  • Maintaining up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting.

  • Collaborating with cross-functional teams, including clinical, regulatory, and data management, to resolve reporting issues.

  • Ensuring timely submission of safety reports to regulatory authorities and sponsors.


Qualifications:

  • Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field.

  • Experience: Experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting processes and regulatory requirements.

  • Excellent attention to detail and organizational skills.

  • Strong communication and collaboration skills, with experience working effectively within a multidisciplinary team.

  • Ability to manage multiple tasks and prioritize effectively in a fast-paced, regulated environment.


What ICON Offers:

  • Competitive salary and benefits.

  • Annual leave entitlements.

  • Health insurance offerings for you and your family.

  • Retirement planning offerings.

  • Global Employee Assistance Programme (LifeWorks) for well-being.

  • Life assurance and flexible country-specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, etc.


Additional Information:

ICON values inclusion and belonging, providing a workplace free of 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.
Reasonable accommodations are available for candidates with medical conditions or disabilities during the application process or job performance.