ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success.
Post : PV Associate/Sr PV Associate
Job Description
Review and process safety events (pre-marketing, post-marketing, medical 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.
• Generates data listings from the safety database and assumes responsibility for accuracy of the data.
• 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.
• Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project.
• Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER
• Support Qualified Person for Pharmacovigilance 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 Pharmacovigilance Project lead (as applicable)
• Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings.
• Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.
• Supports interim data analysis for DMC reviews.
• Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process.
• Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines.
• Supports Safety Scientist in signal detection and risk management activities.
• Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.
• Proposes solutions for procedural and technical issues.
• Supports audits and inspections as required for the assigned projects.
• Perform other activities as identified and requested by management including but not limited to:
• 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.
• Collecting and reviewing adverse event reports to ensure accurate and timely reporting in accordance with regulatory guidelines.
• Conducting signal detection and risk assessment activities to identify potential safety issues.
• Collaborating with cross-functional teams to support safety-related inquiries and investigations.
• Maintaining up-to-date knowledge of pharmacovigilance regulations and industry best practices.
• Assisting in the preparation of safety reports and regulatory submissions.
Candidate Profile
• Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred.
• Experience in pharmacovigilance, drug safety, or a related area, preferably within a clinical or pharmaceutical environment.
• Strong analytical skills with attention to detail in data collection and reporting.
• Excellent communication and interpersonal skills, enabling effective collaboration with team members and stakeholders.
• A commitment to maintaining high standards of quality and compliance in all pharmacovigilance activities.
Additional Information
Qualification : Bachelor's degree in life sciences, pharmacy
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : JR127208
End Date : 30th June 2025
Apply Online for PV Associate >>
See All Ph.D Alerts M.Pharm Alerts B.Pharm Alerts MBA Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
