Pharmacovigilance Reporting Associate

Position: Pharmacovigilance Reporting Associate
Location: Chennai, Trivandrum, India
Job Code: JR126918
Company: ICON plc - Full Service & Corporate Support

About ICON:

ICON plc is a world-leading healthcare intelligence and clinical research organization that provides outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. ICON works to accelerate the development of life-saving drugs and devices. Our employees are at the core of our culture, driving the company’s mission of excellence.

Key Responsibilities:

  • Safety Report Submission: Submit Serious Adverse Event (SAE) reports, periodic reports, line listings, and other safety information to clients, regulatory authorities, and other stakeholders within specified timelines.

  • Safety Reporting Intelligence: Release expedited and periodic safety reports in accordance with regulatory guidelines and company procedures.

  • Oversight & Compliance: Oversee assigned projects, ensuring compliance with ICON, sponsor, and regulatory timeframes for safety reporting.

  • Collaboration: Work closely with project team members, investigators, clients, and third-party vendors, ensuring effective communication and relationships across functional units.

  • Documentation: Ensure accurate filing and quality control of documents in the eTMF or other filing solutions for audit readiness.

  • Training & Mentorship: Mentor and provide training to less experienced associates in safety reporting activities.

  • Project Management: Participate in client and internal meetings, ensuring all project requirements are met. Assist in budget tracking and project resource management.

  • Regulatory Updates: Keep up-to-date with current regulations, safety practices, and pharmacovigilance reporting standards.

Qualifications:

  • Education: Bachelor’s degree in life sciences, pharmacy, or a related field.

  • Experience: Experience in pharmacovigilance or drug safety reporting, with a solid understanding of regulatory requirements and reporting processes.

  • Skills:

    • Strong organizational and analytical skills.

    • Proficient in pharmacovigilance databases and Microsoft Office Suite.

    • Excellent communication and collaboration abilities.

    • Attention to detail, with the ability to prioritize and manage multiple tasks in a fast-paced environment.

Benefits:

  • Competitive salary and a comprehensive benefits package.

  • Health insurance options for you and your family.

  • Retirement planning and savings options.

  • Employee Assistance Program (LifeWorks) offering support through a global network of specialists.

  • Life assurance and flexible, country-specific benefits (e.g., childcare, gym memberships, travel subsidies).

  • Career development and continuous learning culture.

To Apply:
Visit the slug link to apply for the role: pharmacovigilance-reporting-associate-chennai-trivandrum-jr126918

Inclusion Statement:
ICON is an equal opportunity employer, committed to creating an inclusive and accessible workplace for all candidates, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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