Job Title: PV Associate/Sr PV Associate
Company: ICON
Location: Chennai
Salary: ₹25,000 – ₹55,000 per Month
About ICON:
ICON is the world’s leading clinical research organization, providing outsourced clinical development and commercialization services to the pharmaceutical industry.
Position Summary:
ICON is hiring PV Associates and Sr PV Associates to handle safety events, manage data, and support various pharmacovigilance activities.
Key Responsibilities:
| Responsibility | Description |
|---|---|
| Review and Process Safety Events | Handle safety events (pre-marketing, post-marketing, medical device, and drug) as per assigned tasks and procedures. |
| Literature Review | Review abstracts and full articles to identify safety information from literature sources for both pre and post-marketed products. |
| Data Management | Generate data listings from the safety database and ensure accuracy. |
| Adverse Event Follow-Up | Complete follow-up for adverse events in writing and/or by phone based on client requirements. |
| Safety Tracking Systems | Provide input and review safety tracking systems for accuracy and quality, and assist in maintaining project files. |
| Case Processing | Perform safety review of clinical and diagnostic data as part of case processing. |
| Safety Management Plan | Develop and implement Safety Management Plans, ensuring project consistency. |
| Post-Marketing Safety Activities | Support post-marketing safety activities such as PSMF, RMP, and PBRER creation. |
| Liaison | Communicate with investigational sites, reporters, sponsors, ICON Medical Monitor, project managers, and other departments regarding safety issues. |
| Out of Scope Activities | Identify out of scope activities with the Pharmacovigilance Project Lead. |
| Meetings | Attend and present at project team and sponsor meetings and teleconferences, including kick-off and investigator meetings. |
| Aggregated Safety Reports | Support data retrieval and other tasks for generating Aggregated Safety Reports. |
| Interim Data Analysis | Support interim data analysis for DMC reviews. |
| Database Maintenance | Maintain the safety database and entry guidelines, ensuring data quality. |
| SAE/AE Reconciliation | Create and execute the SAE/AE reconciliation plan. |
| Signal Detection and Risk Management | Assist Safety Scientists in signal detection and risk management activities. |
| Audit and Inspection Support | Support audits and inspections for assigned projects. |
| Medical Information Inquiries | Respond to and process medical information inquiries, including adverse events and product complaints. |
Qualifications:
| Requirement | Description |
|---|---|
| Education | B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc |
| Experience | 1-3 years in pharmacovigilance |
| Skills | Strong communication, data management, and teamwork skills. |
| Technical Proficiency | Computer literacy and ability to learn new systems. |
How to Apply:
Interested candidates can apply through the “Apply” button or contact Archana Bakkiyarajan for inquiries.