Icon Plc, a global leader in healthcare intelligence and clinical research, is urgently hiring for the position of Pharmacovigilance Associate in Chennai. This dynamic role is pivotal in ensuring patient safety and adherence to regulatory standards. The ideal candidate should have experience in drug safety and hold a Bachelor's or Master's degree in Life Sciences. Join our team and contribute to advancing healthcare worldwide.
About Icon Plc
Icon Plc is renowned for its commitment to delivering high-quality clinical research services. With a strong focus on patient safety and regulatory compliance, we collaborate with healthcare providers and regulators globally to enhance patient outcomes. Our team is dedicated to excellence and innovation in the field of clinical research.
Role and Responsibilities
As a Pharmacovigilance Associate, you will play a crucial role in monitoring and ensuring the safety of medical products. Your responsibilities will include:
Safety Event Review and Processing
- Review and process safety events (pre-marketing, post-marketing, medical device, and drug) following project-specific procedures.
- Perform literature review to identify safety information for both pre and post-marketed products.
- Generate and ensure the accuracy of data listings from the safety database.
Adverse Event Follow-Up
- Complete adverse event follow-up in writing and/or by phone based on client requirements.
- Provide input and review relevant safety tracking systems for accuracy and quality.
Safety Review and Management
- Perform safety review of clinical and diagnostic data as part of case processing.
- Develop and maintain the Safety Management Plan, ensuring consistency within the project.
- Support the creation of post-marketing safety activities, such as PSMF, RMP, and PBRER.
Stakeholder Liaison
- Liaise with investigational sites, reporters, sponsors, ICON Medical Monitors, project managers, and other departments regarding safety issues.
- Attend project team and sponsor meetings, presenting safety processes as required.
Support and Compliance
- Assist with identifying out-of-scope activities with the Pharmacovigilance Project Lead.
- Support the generation of aggregated safety reports and interim data analysis for DMC reviews.
- Maintain the safety database and ensure quality data through established control processes.
- Support audits and inspections as required for assigned projects.
Qualifications
- Must-Have:
- Bachelor's or Master's degree in Life Sciences or a related field.
- Proven experience in drug safety and regulatory affairs.
- Strong knowledge of local and global regulatory guidelines.
- Excellent communication, collaboration, and problem-solving skills.
- Fluent in English, both written and spoken.
- Proficiency in computer systems and ability to learn new applications.
- Nice-to-Have:
- Knowledge of regulatory processes and therapeutic areas.
- Strategic thinking with strong project management skills.
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ICON PLC Hiring Pharmacovigilance Associate[/caption]
Application Process
Interested candidates are invited to apply online through the
Icon Plc Careers Portal. For inquiries, you can reach out to Archana Bakkiyarajan, who manages this role.
Work Location
- Location: Chennai, India
- Work Type: Full-time, Hybrid (Office/Remote)
Equal Opportunity Employer
Icon Plc is an equal opportunity employer and complies with all applicable equal employment opportunity legislation. We encourage diversity and are committed to creating an inclusive environment for all employees.
https://pharmastuff.org.in/job/icon-plc-pharmacovigilance-associate-chennai
