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Pharmacovigilance Reporting Specialistico

4-6 years
Not Disclosed
10 Nov. 20, 2024
Job Description
Job Type: Full Time Remote 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

Pharmacovigilance Reporting Specialist – Sofia, Bulgaria

ICON plc is a global leader in healthcare intelligence and clinical research. We specialize in advancing the development of drugs, devices, and therapies that improve lives. At ICON, we foster an inclusive environment where innovation and excellence thrive. Join us in shaping the future of clinical development!

Key Responsibilities:

  • Safety Reporting: Submit expedited Serious Adverse Event (SAE) reports, periodic reports, and line listings to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, and ICON personnel, adhering to project timelines.
  • Regulatory Reporting: Release safety intelligence reports within specified timelines, ensuring compliance with ICON’s safety reporting processes.
  • Process Expertise: Provide in-depth expertise on all aspects of safety reporting and safety reporting intelligence. Ensure accurate and timely reporting according to ICON SOPs, Working Procedures, and regulatory requirements.
  • Project Oversight: Lead and oversee assigned projects, ensuring all ICON, sponsor, and regulatory timeframes are met for safety information reporting.
  • Collaboration: Work closely with cross-functional teams, including project members, clients, and third-party vendors, to maintain strong relationships and ensure safety data accuracy.
  • Documentation & Filing: Maintain project information and ensure proper filing and quality control for audit readiness and inspection preparedness.
  • Standard Operating Procedures (SOPs): Assist in the development of departmental SOPs and Work Procedures for safety reporting activities.

Requirements:

  • Education: Bachelor's degree in Life Sciences.
  • Experience: 4 to 6 years of experience in pharmacovigilance or a related field.
  • Language Skills: Fluency in English.

Benefits:

ICON values its people and offers competitive compensation, excellent career development opportunities, and a comprehensive benefits package, including health insurance, retirement planning, and wellness programs. We support our employees’ personal and professional growth with a strong commitment to diversity, inclusion, and work-life balance.

ICON is an equal opportunity employer. We are committed to a workplace free from discrimination and harassment, providing equal consideration for all applicants.