Pharmacovigilance Reporting Specialist

4-6 years

Not Disclosed

Remote, USA

10 Nov. 21, 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 Title: Pharmacovigilance Reporting Specialist - Bulgaria, Sofia

Company: ICON plc

Location: Sofia, Bulgaria

Job Overview:
ICON plc is a leading healthcare intelligence and clinical research organization, dedicated to advancing the development of drugs and medical devices that improve and save lives. We are looking for a Pharmacovigilance Reporting Specialist to join our team and play a crucial role in safety reporting and ensuring compliance with regulatory requirements.

Key Responsibilities:

SAE Reporting: Submission of expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and other safety information to clients, regulatory authorities, ethics committees, investigators, third-party vendors, and ICON personnel as per project timelines.
Safety Reporting Intelligence: Release of safety reporting intelligence, ensuring all expedited and periodic reports, line listings are provided to regulatory authorities, ethics committees, and investigators within specified timelines.
Process Oversight: Provide in-depth expertise in all aspects of safety reporting and maintain a comprehensive understanding of ICON’s safety reporting systems, Standard Operating Procedures (SOPs), and regulatory requirements.
Project Oversight: Operate in a lead capacity to ensure ownership and accountability for safety reporting activities, meeting all ICON, sponsor, and regulatory timeframes for safety reporting.
Documentation & Filing: Perform filing and quality control of documents submitted to the eTMF or other filing solutions, ensuring file readiness for audits or inspections.
Collaboration & Client Engagement: Work closely with project teams, clients, investigators, adverse event reporters, and third-party vendors to maintain good relationships and ensure timely, high-quality reporting.
SOP Development: Assist in the development of departmental SOPs and work procedures, ensuring compliance with industry standards and ICON's internal guidelines.

Requirements:

Education: Bachelor’s degree in life sciences.
Experience: 4 to 6 years of experience in pharmacovigilance, safety reporting, or related roles.
Language Skills: Fluency in English (both written and spoken).

Benefits of Working at ICON:

ICON offers a comprehensive and competitive reward package that includes:

Annual Leave: Generous annual leave entitlements.
Health Insurance: Multiple health insurance options tailored to you and your family’s needs.
Retirement Planning: Competitive retirement plans.
Global Employee Assistance: Access to a global network of professional assistance through LifeWorks.
Life Assurance & Other Benefits: Additional benefits include life assurance, childcare vouchers, gym memberships, travel passes, and more.

Why ICON?

At ICON, we foster a culture of innovation and inclusion where our employees are at the core of our success. We are committed to diversity and inclusion, and our rich diversity drives creativity and helps us deliver better outcomes for our clients, patients, and communities.

If you are interested in this role, but unsure whether you meet all the requirements, we encourage you to apply. We believe that you may be exactly what we are looking for.

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Pharmacovigilance Reporting Specialist

Job Description

Key Responsibilities:

Requirements:

Benefits of Working at ICON:

Why ICON?

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