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Pharmacovigilance Reporting Specialist

4-6 years
Not Disclosed
10 Sept. 26, 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

Job Opportunity: Pharmacovigilance Reporting Specialist

Location: Sofia, Bulgaria

Company: ICON plc

ICON plc is a leading healthcare intelligence and clinical research organization dedicated to innovation and excellence in clinical development. We invite you to join us in our mission to advance drug and device development, enhancing patient outcomes and quality of life.

Key Responsibilities:

  • Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and safety information to clients, Regulatory Authorities, Ethics Committees, and other stakeholders within specified timelines.
  • Release safety reporting intelligence for expedited and periodic reports in accordance with company procedures.
  • Provide expert guidance on all aspects of safety reporting and processes.
  • Maintain a thorough understanding of ICON’s safety reporting systems, processes, and Standard Operating Procedures (SOPs).
  • Oversee safety reporting services and ensure compliance with ICON, Sponsor, and regulatory timelines.
  • Lead safety reporting activities for assigned projects, ensuring accuracy and adherence to regulatory requirements.
  • Support Safety Reporting Group management with quality metrics, finance tracking, client engagement, and training oversight.
  • Collaborate effectively with project teams, clients, investigators, and third-party vendors to build strong working relationships.
  • Manage project information within multiple databases and ensure quality control of documentation submitted to the eTMF.
  • Assist in the development of departmental SOPs and Work Procedures.

Requirements:

  • Bachelor’s degree in life sciences.
  • 4 to 6 years of relevant experience in pharmacovigilance.
  • Fluency in English.

Benefits of Working at ICON:

At ICON, we prioritize the development and well-being of our employees. We offer a competitive total reward package that includes:

  • Comprehensive annual leave entitlements.
  • Health insurance options tailored to you and your family.
  • Competitive retirement planning benefits.
  • Global Employee Assistance Program for 24/7 support.
  • Flexible benefits, including childcare vouchers, discounted gym memberships, and health assessments.

Commitment to Diversity:

ICON is an equal opportunity employer, committed to 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 veteran status.

If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please let us know.

Interested in the Role?

If you’re passionate about pharmacovigilance but unsure if you meet all the requirements, we encourage you to apply. You might be exactly what we’re looking for at ICON!

For more information on our benefits and to apply, visit our careers site.

Are you a current ICON employee? Please click here to apply directly.