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Safety Science Coordinator Ii

2+ years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Job Title: Safety Science Coordinator II – Pune (On-site)

Location: Pune, India
Category: Clinical & Pharmacovigilance
Company: Fortrea
Work Mode: On-site
Experience Required: 2+ years
Salary: Not specified


Job Summary

Fortrea is hiring a Safety Science Coordinator II for its Pune office. This role focuses on end-to-end adverse event processing, safety report submissions, and pharmacovigilance compliance. Ideal for candidates with 2+ years of experience in pharmacovigilance, this role ensures regulatory safety reporting, documentation, and collaboration across clinical and post-marketing safety operations.


Key Responsibilities

  • Process and manage adverse event reports from various sources.

  • Perform data entry, tracking, and case assessment for completeness and accuracy.

  • Write patient narratives and code AEs using MedDRA.

  • Generate queries for missing clinical information; consult with medical reviewers when needed.

  • Prioritize and submit expedited safety reports (ESRs) to clients and regulatory authorities within timeline requirements.

  • Assist in database reconciliation, quality review, and documentation.

  • Support reporting of periodic safety reports (PSRs).

  • Train and mentor team members as needed.

  • Maintain compliance with SOPs, regulatory guidelines, and pharmacovigilance best practices.

  • Contribute to audit and inspection readiness.


Required Skills & Qualifications

  • Education: PharmD, MPharm, BPharm (preferred disciplines: Pharmacy, Life Sciences, Nursing, or Medical Sciences).

  • Experience: Minimum 2 years in pharmacovigilance or clinical safety roles.

  • Strong knowledge of adverse event processing, MedDRA coding, and safety databases.

  • Proficient in MS Office; accurate data entry and documentation.

  • Good verbal and written communication skills.

  • Ability to work independently and in cross-functional teams.

  • Familiarity with ICH-GCP, local regulatory requirements, and case reporting timelines.


Perks & Benefits

  • Work with a global leader in clinical trials and pharmacovigilance.

  • Exposure to both clinical trial and post-marketing safety reporting.

  • Professional development in regulatory safety and drug monitoring.

  • Supportive team culture with peer mentorship opportunities.

  • Stable and structured work environment.


Company Overview

Fortrea is a global clinical research and drug development company providing advanced solutions across the pharmaceutical and healthcare industries. With a focus on compliance, safety, and data-driven clinical excellence, Fortrea supports life sciences innovation from early development to post-marketing surveillance.


Work Mode

On-site – Pune, India


Call to Action

Are you ready to advance your career in clinical safety and pharmacovigilance? Apply today for the Safety Science Coordinator role and join a global team committed to improving drug safety and patient outcomes.