Safety Reporting Coordinator

At PPD-Pharmaceutical Product Development, we are dedicated to helping our clients bring life-changing medicines to market. As the Safety Reporting Coordinator, you will play a crucial role in ensuring the safety and well-being of patients by managing safety reporting activities for our clinical trials. We are seeking a highly organized and detail-oriented individual with a strong understanding of pharmacovigilance regulations and experience in safety reporting. If you are passionate about making a difference in the pharmaceutical industry and have the necessary qualifications, we encourage you to apply.

1. Manage safety reporting activities for all clinical trials, ensuring timely and accurate submission of safety reports to regulatory agencies and internal stakeholders.
2. Monitor safety data and identify any potential safety concerns, escalating to appropriate team members for further investigation.
3. Maintain a thorough understanding of pharmacovigilance regulations and guidelines to ensure compliance in all safety reporting activities.
4. Collaborate with cross-functional teams to ensure a comprehensive safety reporting process for all clinical trials.
5. Develop and maintain standard operating procedures (SOPs) for safety reporting, ensuring adherence to industry best practices.
6. Oversee the tracking and reconciliation of all safety data, including adverse events, serious adverse events, and safety signals.
7. Liaise with external partners, including contract research organizations (CROs) and clinical sites, to facilitate safety reporting and data collection.
8. Participate in safety review meetings and provide updates on safety reporting activities to relevant stakeholders.
9. Conduct training and provide guidance to team members on safety reporting procedures and regulations.
10. Continuously evaluate and improve safety reporting processes to ensure maximum efficiency and accuracy.
11. Keep abreast of industry developments and changes in safety reporting regulations to ensure compliance and best practices are maintained.
12. Act as a point of contact for safety reporting inquiries and provide timely responses to internal and external stakeholders.
13. Maintain accurate and up-to-date documentation of all safety reporting activities and ensure proper archiving for regulatory purposes.
14. Collaborate with quality assurance teams to ensure compliance with safety reporting requirements during audits and inspections.
15. Foster a culture of patient safety by promoting awareness and understanding of safety reporting processes among team members.

According to JobzMall, the average salary range for a Safety Reporting Coordinator in Bengaluru, Karnataka, India is between ₹300,000-₹600,000 per year. This equates to approximately $4,000-$8,000 USD per year. However, salaries may vary depending on the specific company, level of experience, and other factors.

PPD, Inc. is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.