ICON PLC Hiring Senior Pharmacovigilance Associate

ICON PLC Hiring Senior Pharmacovigilance Associate

Location: CHENNAI

Job Reference: JR116173

Department: DRUG SAFETY ICON FULL SERVICE & CORPORATE SUPPORT OFFICE BASED

About the Role

At ICON, our people set us apart. Our diverse teams enable us to become a better partner to our customers and help us fulfill our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values: Accountability & Delivery, Collaboration, Partnership, and Integrity. We strive to be the Clinical Research Organization that delivers excellence to our clients and patients at every touch-point.

If you share our vision and are as driven as we are, join us. You’ll work in a dynamic and supportive environment, alongside some of the brightest and friendliest people in the sector, shaping an industry.

Roles & Responsibilities:

• Review and process serious adverse events, spontaneously reported adverse reactions, and/or other medically related information per assigned tasks and study-specific procedures.
• Conduct literature surveillance in selected databases as outlined in the project scope of work and established procedures.
• Provide input and review relevant safety tracking systems for accuracy and quality, assisting with maintaining project files.
• Perform safety review of clinical and diagnostic data for case processing.
• Assist with the generation of regulatory reports as necessary to ensure compliance.
• Liaise with other ICON departments, investigational sites, reporters, and/or Sponsors regarding safety issues.
• Assist with coordination of interdepartmental activities.
• Serve as Functional Lead on case processing or medical information projects, coordinating teams of Pharmacovigilance associates.
• Support creation of the SAE/AE reconciliation plan and support SAE reconciliation.
• Maintain the safety database and corresponding entry guidelines.
• Support analysis and quality control during the generation of Aggregated Safety Reports.
• Support Safety Scientist in signal detection and risk management activities.
• Participate in internal and client project team meetings.
• Adhere to financial and administrative processes.
• Support audits and inspections as required for assigned projects.
• Act as Subject Matter Expert in departmental initiatives.
• Contribute to business development efforts in Drug Safety.

Criteria:

• 4+ years of work experience in safety background.
• Experience working in ICSR.
• Bachelor’s or Master’s degree.

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer competitive salary packages, annual bonuses, health-related benefits, and retirement plans, among others. You’ll also benefit from an environment where you are encouraged to fulfill your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer committed to providing a workplace free of discrimination and harassment.

If you need a reasonable accommodation for any part of the application process, please let us know.