Icon Plc Hiring Senior Pharmacovigilance Reporting Associate

Icon Plc as a Senior Pharmacovigilance Reporting Associate in Chennai & Trivandrum

Icon Plc invites talented individuals to join us as a Senior Pharmacovigilance Reporting Associate in Chennai or Trivandrum. Discover a rewarding career with Icon Plc and be part of a dynamic team dedicated to improving patient outcomes.

Icon Plc is a leading Clinical Research organization (CRO) committed to advancing healthcare and enhancing patient lives. As a Senior Pharmacovigilance Reporting Associate, you will play a crucial role in ensuring the timely and accurate reporting of safety information. Read on to learn more about this exciting opportunity and how you can be part of our mission-driven team.

Pharmacovigilance Job Details:

Location: Chennai, Trivandrum

Job Number: JR116190

Department: Drug Safety, Icon Full Service & Corporate Support, Hybrid: Office/Remote

About Icon Plc:

At Icon, we are driven by our values of Accountability & Delivery, Collaboration, Partnership, and Integrity. Our ‘Own It’ culture empowers individuals to excel and make a difference in the pharmaceutical industry. Join us in our vision to be the partner of choice in drug development and deliver excellence at every step.

Responsibilities of the Senior Pharmacovigilance Reporting Associate:

• Preparing and submitting adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness.
• Collaborating with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals for further investigation.
• Assisting in the preparation of periodic safety update reports (PSURs), annual reports, and other regulatory documents to ensure compliance with reporting obligations.
• Monitoring timelines for safety report submissions and proactively managing any delays or issues that may arise in the reporting process.
• Maintaining and updating pharmacovigilance databases, ensuring the integrity and quality of safety data through meticulous data entry and validation.
• Providing training and support to junior team members on reporting procedures and pharmacovigilance regulations to enhance team capabilities.
• Engaging in audits and inspections by regulatory authorities, ensuring readiness and adherence to all relevant pharmacovigilance reporting requirements.
• Staying informed about changes in regulatory guidelines and industry standards to ensure ongoing compliance and best practices in pharmacovigilance reporting.

Your Profile:

• Bachelor’s degree in life sciences, pharmacy, or a related field. An advanced degree is preferred.
• Extensive experience in pharmacovigilance or drug safety reporting, with a strong understanding of relevant regulations and guidelines.
• Proven ability to prepare and submit accurate adverse event reports and safety data in a timely manner.
• Strong analytical skills, with the ability to interpret safety data and identify trends or issues requiring further action.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
• Proficiency in pharmacovigilance databases and reporting tools, as well as Microsoft Office Suite.
• Ability to manage multiple projects and priorities in a fast-paced environment while maintaining attention to detail.
• Commitment to maintaining confidentiality and handling sensitive patient information with discretion.

Benefits of Working at Icon Plc:

• Competitive salary packages and annual bonuses based on performance goals.
• Health-related benefits for employees and their families, including retirement plans and life assurance.
• Opportunities for career growth, training, and development in a supportive environment.

Icon Plc is committed to diversity, inclusion, and equal opportunities. We welcome applicants from diverse backgrounds and are dedicated to providing a workplace free of discrimination and harassment.

Apply Now:

If you are passionate about pharmacovigilance and are looking for a rewarding career with a global leader in healthcare, Icon Plc invites you to apply for the Senior Pharmacovigilance Reporting Associate position at Icon Plc.