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Pharmacovigilance Reporting Associate

Freshers years
2-4 LPA
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D 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 Associate

Locations:

  • India, Chennai
  • India, Trivandrum

Time Type:
Full-Time

Posted On:
6 Days Ago

Job Requisition ID:
JR124495


About ICON plc

ICON plc is a global leader in healthcare intelligence and clinical research. We are committed to fostering an inclusive, innovative, and excellent environment. Join us in our mission to shape the future of clinical development.


Key Responsibilities

  1. Safety Reporting:

    • Submission of expedited Serious Adverse Event (SAE) reports, periodic reports, line listings, and safety information to clients, Regulatory Authorities, Ethics Committees, investigators, and other relevant stakeholders.
    • Ensure timely release of safety reporting intelligence for expedited and periodic reports in line with company procedures.
  2. Compliance and Oversight:

    • Maintain a thorough understanding of ICON's safety reporting systems, Standard Operating Procedures (SOPs), and Working Procedures (WPs).
    • Oversee assigned projects to ensure regulatory, sponsor, and ICON timelines are met.
    • Operate as the lead for safety reporting activities, ensuring ownership and accountability.
  3. Quality Assurance:

    • Ensure accurate completion of project activities per ICON standards, regulatory requirements, and client agreements.
    • Conduct quality control and filing of documents for audits and inspections.
  4. Collaboration and Leadership:

    • Collaborate with clients, investigators, project team members, and third-party vendors to maintain strong professional relationships.
    • Coach and mentor junior associates on safety reporting processes.
  5. Project Management:

    • Manage routine project activities, including client meetings, investigator presentations, and budget considerations.
    • Represent the Safety Reporting department in internal and client meetings.
  6. Regulatory Awareness:

    • Stay updated on regulatory changes, practices, and proposals related to safety reporting.
    • Prepare for audits and inspections, ensuring readiness and compliance.
  7. Other Responsibilities:

    • Travel (approximately 10%) domestically or internationally as required.
    • Perform additional tasks as identified by management.

What ICON Can Offer You

ICON values its people and fosters a diverse, inclusive culture that rewards performance and nurtures talent.

Benefits Include:

  • Competitive salary with country-specific benefits.
  • Various annual leave entitlements.
  • Health insurance options for you and your family.
  • Retirement planning for financial security.
  • Global Employee Assistance Programme for well-being support.
  • Life assurance and optional benefits like childcare vouchers, gym discounts, travel subsidies, etc.

Diversity, Inclusion & Belonging

At ICON, diversity is at the core of our values. We are committed to creating an inclusive, accessible environment free from discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, gender, sexual orientation, national origin, disability, or veteran status.


Ready to Shape the Future of Clinical Development? Apply now to join our global team!