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About Company

ICON is the world's leading clinical research organisation, providing outsourced clincal development and commercialisation services to the pharmaceutical

Position Name :

PV Associate/Sr PV Associate

Organization :



B.Pharm, M.Pharm, Pharm.D, Msc, BSc


1 Year - 3 Years


25,000 - 55,000 /month



  • Review and Process Safety Events: Handle safety events (pre-marketing, post-marketing, medical device, and drug) and other medically related information per assigned tasks and project-specific procedures.
  • Literature Review: Perform review of 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 the accuracy of the data.
  • Adverse Event Follow-Up: Complete adverse event follow-up in writing and/or by phone based on requirements for each client.
  • Safety Tracking Systems: Provide input and review relevant safety tracking systems for accuracy and quality, and assist with maintaining project files.
  • Case Processing: Perform safety review of clinical and diagnostic data as part of case processing.
  • Safety Management Plan: Develop and implement the Safety Management Plan, ensuring consistency within the project.
  • Post-Marketing Safety Activities: Support the creation of post-marketing safety activities, such as PSMF, RMP, and PBRER.
  • Liaison: Communicate with investigational sites, reporters, sponsors, ICON Medical Monitor, project managers, and other departments regarding safety issues.
  • Out of Scope Activities: Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project Lead.
  • Meetings: Attend project team and sponsor meetings and teleconferences, including presenting the safety process at kick-off and investigator meetings.
  • Aggregated Safety Reports: Support the generation of Aggregated Safety Reports through data retrieval and other assigned tasks.
  • Interim Data Analysis: Support interim data analysis for DMC reviews.
  • Database Maintenance: Maintain the safety database and corresponding entry guidelines, ensuring data quality following established quality control processes.
  • SAE/AE Reconciliation: Support the creation and execution of 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 those related to adverse events and product complaints for clients’ products.

Application Instructions: Interested candidates can apply through the “Apply” button or shortlist the job. For inquiries, contact Archana Bakkiyarajan.

Application Link