Job Summary:
• Perform processing for all types of safety events, medical information call handling activities and other medically-related project information. 
• Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information
• Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.

Key Responsibilities:

• Review and process safety events (pre-marketing, post-marketing, device and drug) and/or other medically related information per assigned tasks and project specific procedures*
•Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products.
• Respond and process medical information inquiries including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON. 
• Complete adverse event follow-up in writing and/or by phone based on requirements for each Client.
• Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files*
• Perform safety review of clinical and diagnostic data as part of case processing*
• Assist with generation of project specific procedures
• Act as lead Drug Safety Associate for local or regional projects*
• Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER
• Support QPPV as required
• Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
• Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate*
• Assist with identifying out of scope activities in conjunction with the PV Project lead (as applicable)
• Attend project team and Sponsor meetings (including Investigator meetings) and teleconferences as required
• Perform other activities as identified and requested by management.
You will need:
• The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
• Must be fluent in written and verbal English with good communication skills and basic computer skills. Detail orientated and capable of working effectively within a team environment.
• Medical/science background (nursing preferred) and/or bachelor’s degree or local equivalent.

Apply : https://careers.iconplc.com/job/drug-safety-associate-in-india-chennai-jid-25007