Job title:Safety and pv specialist 1

Location:gurugram

Job Profile:
Responsibilities

• Manage Individual Case Safety Reports (ICSRs) by entering, tracking, triaging, and processing in compliance with SOPs and safety plans.

• Ensure completeness, accuracy, and regulatory compliance of ICSR data and narratives.

• Conduct medical coding using MedDRA for events, medical history, medications, and tests.

• Perform literature screening, drug dictionary maintenance, and duplicate case management.

• Validate and submit xEVMPD product records and manage SPOR/IDMP activities.

• Generate expedited safety reports in line with regulatory requirements.

• Participate in quality review of ICSRs, audits, and submission of documents to TMF or Pharmacovigilance System Master File.

• Maintain adherence to regulatory guidelines (GCP, ICH, GVP) and foster effective teamwork.

Qualifications

• Bachelor’s degree in life sciences, nursing, or pharmacy, or equivalent education/experience.

• Knowledge of safety database systems and medical terminology.

• Strong understanding of clinical trial phases, safety regulations, ICH GCP, and GVP.

• Proficiency in Microsoft Office Suite and collaborative tools like TeamShare.

• Exceptional communication, organizational, and interpersonal skills.

• Ability to prioritize tasks, work independently, and ensure high attention to detail.

This role demands a proactive individual capable of managing complex pharmacovigilance activities, ensuring regulatory compliance, and contributing to patient safety initiatives.