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Pharmacovigilance Reporting Specialist

4+ years
Not Disclosed
10 April 29, 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

Pharmacovigilance Reporting Specialist
Employer: ICON Plc
Location: Bulgaria, Homeworking (Sofia office-based approx. 3 days/week)
Salary: Competitive
Start Date: 31 March 2025
Closing Date: 30 April 2025


About ICON Plc:

ICON plc is a leading global provider of healthcare intelligence and clinical research. We are committed to innovation, inclusivity, and delivering high-quality solutions that drive progress in clinical development.


Position Overview:

ICON is hiring a Pharmacovigilance Reporting Specialist to join our dedicated pharmacovigilance team. In this role, you will prepare and analyze safety data to support regulatory compliance and patient safety, contributing to ICON’s high standards in drug safety and reporting.


Key Responsibilities:

  • Prepare and submit safety reports including Periodic Safety Update Reports (PSURs) and Individual Case Safety Reports (ICSRs) in compliance with global regulations.

  • Conduct data analysis to identify safety trends and support risk assessments.

  • Collaborate across clinical, regulatory, and safety teams to ensure accurate and timely reporting of adverse events.

  • Maintain current knowledge of pharmacovigilance guidelines and industry best practices.

  • Train and support team members on pharmacovigilance processes and compliance standards.


Candidate Profile:

  • Bachelor’s degree in Life Sciences, Pharmacy, or related field (advanced degree preferred).

  • Minimum of 4 years of experience in pharmacovigilance reporting or drug safety.

  • Proven project lead experience is essential.

  • Strong analytical abilities with proficiency in data analysis tools and reporting software.

  • Excellent interpersonal and communication skills for collaboration with internal and external stakeholders.

  • High standard of compliance and quality in pharmacovigilance activities.

  • Fluency in English is required.


What ICON Offers:

  • Competitive salary and a full benefits package.

  • Health insurance options tailored for you and your family.

  • Retirement savings and planning support.

  • Access to the Global Employee Assistance Programme (LifeWorks).

  • Life assurance and country-specific flexible benefits.

  • Wellness support, gym memberships, childcare vouchers, and more.


ICON is an Equal Opportunity Employer. We are committed to creating a supportive, inclusive, and accessible workplace. Candidates requiring accommodations during the hiring process are encouraged to make a request.