Pharmacovigilance Reporting Associate

0-2 years

Not Disclosed

Chennai

10 Dec. 20, 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 Associate
Location: ICON plc
Job Posting Date: [Insert Date]

Job Overview:
ICON plc, a world-leading healthcare intelligence and clinical research organization, is looking for a Pharmacovigilance Reporting Associate to join our team. We are committed to fostering an inclusive environment and driving innovation in clinical development. If you're passionate about contributing to the future of clinical research, we'd love for you to be part of our team.

Key Responsibilities:

Submit expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and relevant safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, partners, and ICON personnel as per project timelines.
Provide safety reporting intelligence for expedited and periodic reports, line listings, ensuring compliance with company procedures and regulatory requirements.
Maintain a deep understanding of ICON’s safety reporting systems, processes, Standard Operating Procedures (SOPs), and working procedures (WPs).
Oversee assigned projects to ensure compliance with ICON, sponsor, and regulatory timeframes for safety reporting activities.
Lead safety reporting activities on assigned projects, ensuring accountability and quality control.
Support Safety Reporting Group management in departmental activities, such as quality reviews, finance tracking, and project resource tracking.
Collaborate effectively with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.
Work within multiple databases to manage project or pharmacovigilance intelligence information and ensure timely updates.
Maintain project files and ensure quality control of documents submitted for audits or inspections.
Prepare for and represent the department in audits and inspections as designated.
Stay updated on the latest regulatory and safety reporting intelligence practices and regulations.
Mentor and coach less experienced associates in safety reporting tasks.
Coordinate routine project activities, such as client meetings, presentations, responses to stakeholders, and budget considerations.
Travel domestically and internationally (approximately 10%) as needed.

What ICON Can Offer You: At ICON, we prioritize the well-being and development of our employees. In addition to a competitive salary, we offer a range of benefits designed to support your work-life balance and personal needs, including:

Various annual leave entitlements
Health insurance offerings tailored to you and your family’s needs
Retirement planning options to maximize savings
Global Employee Assistance Program offering 24/7 support
Life assurance and flexible, country-specific benefits (e.g., childcare vouchers, discounted gym memberships)

Our Culture & Values: Diversity, inclusion, and belonging are at the heart of ICON’s culture. We believe that a diverse workforce fosters innovation and helps us better serve our patients, clients, and communities. ICON is dedicated to providing a workplace free of discrimination and harassment, offering equal employment opportunities to all qualified applicants.

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

Application Instructions: If you're interested in this role but unsure if you meet all the requirements, we encourage you to apply anyway. You may be exactly what we’re looking for at ICON, whether for this position or another.

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Pharmacovigilance Reporting Associate

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