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Patient Safety Associate I

Freshers years
3-5 LPA
10 Nov. 18, 2025
Job Description
Job Type: Full Time Education: B.Pharm, M.Pharm, Pharm D., BSc., MSc. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Patient Safety Associate I – Parexel (Hyderabad, India)

Experience Required: 0–2 years (Fresher-Friendly Role)
Employment Type: Full-Time
Application Deadline: November 20, 2025
Job ID: R0000035109

Parexel is hiring a fresher-friendly Patient Safety Associate I to support global drug safety, ICSR processing, and medical monitoring activities across clinical trials and post-marketing surveillance. This role is ideal for fresh graduates or early-career professionals seeking to begin their journey in pharmacovigilance within a global CRO.


Role Overview

The Patient Safety Associate I ensures accurate processing of Individual Case Safety Reports (ICSRs), regulatory compliance, and safety data quality. This entry-level position offers structured training, exposure to global PV workflows, and a strong foundation for a long-term pharmacovigilance career.


Key Responsibilities

ICSR Processing & Safety Operations

  • Process ICSRs from multiple clinical and post-marketing sources.

  • Conduct triage for completeness and regulatory validity.

  • Perform data entry, coding, and follow-up activities in safety databases.

  • Draft high-quality patient case narratives.

  • Maintain safety files, project documentation, and reporting logs.

Regulatory Reporting & Compliance

  • Support global and local regulatory submissions.

  • Assist with expedited reporting procedures and SUSAR unblinding.

  • Perform literature searches to support signal detection and safety surveillance.

  • Participate in quality control, metrics tracking, and compliance monitoring.

  • Prepare documentation for audits and inspections.

Project & Clinical Support

  • Assist in the creation of study-specific safety workflows, templates, and SOPs.

  • Support UAT during safety database setup.

  • Collaborate with Safety Physicians and Medical Directors during medical monitoring activities.

  • Attend investigator meetings and internal training.

  • Facilitate submissions via systems such as ISIS (International Safety Information System).


Skills & Core Competencies

  • Strong analytical and problem-solving skills

  • Ability to conduct structured database and literature searches

  • Clear written and verbal communication

  • Strong prioritization and organization abilities

  • Team-driven and client-focused mindset

  • Comfort using safety databases and standard software tools


Preferred Experience

  • Fresher applicants accepted

  • Any internship, training, or basic exposure to pharmacovigilance, drug safety, medical coding, or clinical research is an advantage


Educational Qualifications

  • Postgraduate in Pharmacy, Pharmacovigilance & Clinical Research
    or

  • Bachelor of Dentistry (BDS)
    or

  • Life science degree with fundamental understanding of drug safety operations