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Pharmacovigilance Reporting Specialist

2+ years
Not Disclosed
10 Nov. 5, 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

Senior Pharmacovigilance Reporting Associate

Location: Bulgaria
Company: ICON plc


About ICON:

ICON plc is a leading global healthcare intelligence and clinical research organization committed to shaping the future of clinical development. We provide innovative and high-quality services to the pharmaceutical, biotechnology, and medical device industries. Join our diverse team to make a real difference in the lives of patients and help improve global healthcare.


Job Role:

As a Senior Pharmacovigilance Reporting Associate, you will be responsible for ensuring the timely submission of safety data and reports related to clinical studies. This includes Serious Adverse Event (SAE) reports, periodic reports, line listings, and other safety information to clients, regulatory authorities, and other stakeholders. You will oversee safety reporting activities for assigned projects, ensuring compliance with regulatory requirements and client agreements. Additionally, you will mentor and support less experienced associates, fostering a collaborative team environment.


Key Responsibilities:

  • Safety Reporting: Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and other safety data to clients, regulatory authorities, ethics committees, and other stakeholders within the agreed timelines.
  • Project Oversight: Ensure that all ICON, sponsor, and regulatory timeframes for safety information are met for assigned projects.
  • Documentation Management: Maintain accurate project information and safety data across multiple databases, ensuring proper filing and quality control for audits and inspections.
  • Collaboration: Build strong working relationships with project teams, clients, investigators, and third-party vendors.
  • Mentorship: Provide coaching and mentoring to less experienced associates in safety reporting and related tasks.
  • Regulatory Compliance: Ensure compliance with ICON Standard Operating Procedures (SOPs), working procedures (WPs), and applicable safety reporting guidelines.
  • Client & Stakeholder Engagement: Participate in client and internal meetings, representing the safety reporting department and addressing any safety reporting concerns.
  • Therapeutic Area Expertise: Maintain an understanding of relevant therapeutic areas and disease states as needed for the projects.
  • Travel: Approximately 10% domestic and/or international travel may be required.
  • Additional Activities: Take on other tasks as identified by management.

What ICON Can Offer You:

ICON recognizes that the success of our company depends on the quality of our people. We are committed to creating an inclusive and diverse work environment that fosters innovation and excellence. We offer a competitive salary and comprehensive benefits to help maintain work-life balance and support your well-being.

Benefits:

  • Various annual leave entitlements
  • Health insurance options to suit you and your family’s needs
  • Competitive retirement planning offerings
  • Global Employee Assistance Program (LifeWorks) with 24-hour support
  • Life assurance coverage
  • Flexible benefits tailored to local markets, including childcare vouchers, bike purchase schemes, discounted gym memberships, and more

Diversity & Inclusion:

At ICON, diversity, inclusion, and belonging are integral to our culture. We embrace a rich diversity that fosters innovation, helping us serve our people, patients, customers, and communities more effectively. We are 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.


How to Apply:

If you are interested in this role, we encourage you to apply, even if you don’t meet all the requirements—there’s a good chance you could be the perfect fit for this or other roles at ICON.


Are you a current ICON employee?
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